Sheets Lyophilized Collagen Heyedrator

FDA-Cleared Indications

• Use as an absorbable hemostatic material to assist in controlling bleeding when conventional methods are ineffective or impractical.
• Use as an embolic material to promote occlusion of blood vessels when indicated.
• Use only according to the cleared labeling, preparation instructions, and intended route of administration.

Clinical Applications

• Adjunctive control of bleeding during surgical or interventional procedures.
• Temporary or targeted vessel occlusion during embolization procedures.
• Management of bleeding from small vessels or diffuse oozing when direct ligation or cautery is difficult.

Reported off-label uses

• Collagen scaffold applications in wound-healing research and selected clinical settings.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The material is lyophilized and must be rehydrated and prepared according to the product labeling before use.
• Collagen products may be derived from porcine tissue; review the labeling and patient history for relevant animal-protein sensitivity or allergy.
• The appropriate amount, size, and preparation depend on the bleeding site, target vessel, delivery method, and intended use; the supplied FDA record does not provide detailed dimensions.
• Do not inject or deliver the material into a vessel unless the specific product labeling authorizes that route and use.
• MRI safety is not established from the provided FDA record. Because this is a collagen material rather than an active electronic implant, MRI concerns are generally related to associated markers, packaging, or other implanted materials; verify the current labeling.