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Seprafilm®

FDA UDI

Class III (US FDA UDI)

by Genzyme Corp.

Identity

Trade Name
Seprafilm® FDA UDI
Generic Name
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
Device Name
Barrier, Absorbable, Adhesion FDA UDI
Model / Reference
4301-02 FDA UDI
Description
Barrier, Absorbable, Adhesion FDA UDI

Identifiers

Primary DI / UDI-DI
00358468430120 FDA UDI
FDA Product Code
MCN FDA UDI
GMDN Term
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Area/Surface Area — 195 Square centimeter FDA UDI

Category: Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

Seprafilm® by Genzyme Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genzyme Corp.

Sources (1)

  • FDA UDI 3fad5a16-8aee-4c98-847f-8ce872d72565 36 fields · synced May 31, 2026