Gelfilm

Basic Information

• Brand Name: Gelfilm
• Primary DI: 00300090283018
• Version / Model: Gelfilm® Sterile Film Sterile film 1's (125 sq cm)
• Company Name: PHARMACIA & UPJOHN COMPANY LLC
• Labeler DUNS: 618054084
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 7
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 565636c1-b397-45f1-8990-183ba206909b
• Distribution End Date: 2016-05-25

Device Description

Anti-adhesion dressing, bioabsorbable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOD	surgical film	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34212	Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated	A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00300090283018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	100	Millimeter
Length	125	Millimeter
Device Size Text, specify			Thickness of film ranges from 0.060 to 0.175 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: See USP Controlled Room Temperature
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius