Coils
Cerepak Uniform
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Cerepak Uniform models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FCX100202 | Length 190 cm; Length 2.5 cm | MR Conditional | Available |
| FCX100253 | Length 190 cm; Length 3.3 cm | MR Conditional | Available |
| FCX100305 | Length 190 cm; Length 5.4 cm | MR Conditional | Available |
| FCX100356 | Length 190 cm; Length 6.6 cm | MR Conditional | Available |
| FCX100407 | Length 190 cm; Length 7.5 cm | MR Conditional | Available |
| FCX100412 | Length 190 cm; Length 11.5 cm | MR Conditional | Available |
| FCX100509 | Length 190 cm; Length 9.7 cm | MR Conditional | Available |
| FCX100517 | Length 190 cm; Length 17 cm | MR Conditional | Available |
| FCX100611 | Length 190 cm; Length 11.9 cm | MR Conditional | Available |
| FCX100626 | Length 190 cm; Length 26 cm | MR Conditional | Available |
| FCX100713 | Length 190 cm; Length 13.9 cm | MR Conditional | Available |
| FCX100730 | Length 190 cm; Length 30 cm | MR Conditional | Available |
| FCX100816 | Length 190 cm; Length 16.1 cm | MR Conditional | Available |
| FCX100829 | Length 190 cm; Length 29 cm | MR Conditional | Available |
| FCX140225 | Length 190 cm; Length 2.5 cm | MR Conditional | Available |
| FCX140303 | Length 190 cm; Length 3 cm | MR Conditional | Available |
| FCX140304 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| FCX140306 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| FCX140406 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| FCX140408 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| FCX140445 | Length 190 cm; Length 4.5 cm | MR Conditional | Available |
| FCX140507 | Length 190 cm; Length 7 cm | MR Conditional | Available |
| FCX140512 | Length 190 cm; Length 12 cm | MR Conditional | Available |
| FCX140609 | Length 190 cm; Length 9 cm | MR Conditional | Available |
| FCX140615 | Length 190 cm; Length 15 cm | MR Conditional | Available |
| FCX140711 | Length 190 cm; Length 11 cm | MR Conditional | Available |
| FCX140717 | Length 190 cm; Length 17 cm | MR Conditional | Available |
| FCX140812 | Length 190 cm; Length 12 cm | MR Conditional | Available |
| FCX140820 | Length 190 cm; Length 20 cm | MR Conditional | Available |
| FCX140914 | Length 190 cm; Length 14 cm | MR Conditional | Available |
| FCX140922 | Length 190 cm; Length 22 cm | MR Conditional | Available |
| FCX141016 | Length 190 cm; Length 16 cm | MR Conditional | Available |
| FCX141025 | Length 190 cm; Length 25 cm | MR Conditional | Available |
| FCX141118 | Length 190 cm; Length 18 cm | MR Conditional | Available |
| FCX141127 | Length 190 cm; Length 27 cm | MR Conditional | Available |
| FCX141219 | Length 190 cm; Length 19 cm | MR Conditional | Available |
| FCX141230 | Length 190 cm; Length 30 cm | MR Conditional | Available |
| FCX180510 | Length 190 cm; Length 10 cm | MR Conditional | Available |
| FCX180612 | Length 190 cm; Length 12.2 cm | MR Conditional | Available |
| FCX180714 | Length 190 cm; Length 14.3 cm | MR Conditional | Available |
| FCX180813 | Length 190 cm; Length 13.6 cm | MR Conditional | Available |
| FCX180830 | Length 190 cm; Length 30 cm | MR Conditional | Available |
| FCX180915 | Length 190 cm; Length 15.3 cm | MR Conditional | Available |
| FCX180933 | Length 190 cm; Length 33 cm | MR Conditional | Available |
| FCX181017 | Length 190 cm; Length 17.1 cm | MR Conditional | Available |
| FCX181034 | Length 190 cm; Length 34 cm | MR Conditional | Available |
| FCX181118 | Length 190 cm; Length 18.9 cm | MR Conditional | Available |
| FCX181137 | Length 190 cm; Length 37 cm | MR Conditional | Available |
| FCX181220 | Length 190 cm; Length 20.7 cm | MR Conditional | Available |
| FCX181240 | Length 190 cm; Length 40 cm | MR Conditional | Available |
| FCX181343 | Length 190 cm; Length 43 cm | MR Conditional | Available |
| FCX181447 | Length 190 cm; Length 47 cm | MR Conditional | Available |
| FCX181550 | Length 190 cm; Length 50 cm | MR Conditional | Available |
| FCX181647 | Length 190 cm; Length 47 cm | MR Conditional | Available |
| FCX181750 | Length 190 cm; Length 50 cm | MR Conditional | Available |
| FCX181846 | Length 190 cm; Length 46 cm | MR Conditional | Available |
| FCX181950 | Length 190 cm; Length 50 cm | MR Conditional | Available |
| FCX182050 | Length 190 cm; Length 50 cm | MR Conditional | Available |
FDA clearances
- 510(k) K220040 July 2022
Procedures that use coils
Frequently asked questions
What is Cerepak Uniform used for?
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Who makes Cerepak Uniform?
Cerepak Uniform is made by Cerenovus, Inc.. It is listed under embolization coils in our device library.
What sizes does Cerepak Uniform come in?
Sizes listed for Cerepak Uniform: Length: 2.5–190 cm. Confirm availability with the manufacturer's instructions for use.
Is Cerepak Uniform MRI safe?
The FDA device database lists Cerepak Uniform as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Cerepak Uniform FDA cleared?
Cerepak Uniform is covered by FDA submission K220040.
How do I contact a Cerenovus, Inc. sales representative?
Cerenovus, Inc. has not listed representatives on LA Vascular yet. Visit the Cerenovus, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.