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Gelfilm

FDA UDI

Class II (US FDA UDI)

by Pharmacia & Upjohn Co.

Identity

Trade Name
Gelfilm FDA UDI
Generic Name
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
Device Name
Anti-adhesion dressing, bioabsorbable FDA UDI
Model / Reference
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm) FDA UDI
Description
Anti-adhesion dressing, bioabsorbable FDA UDI

Identifiers

Primary DI / UDI-DI
00300090297015 FDA UDI
FDA Product Code
HQX FDA UDI
GMDN Term
Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.3340 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 50 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

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

Gelfilm by Pharmacia & Upjohn Co. — Class II — 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
Pharmacia & Upjohn Co.

Sources (1)

  • FDA UDI 7ec9b498-7330-4f1f-924b-7cda50e75fd7 36 fields · synced Jun 1, 2026