AccessGUDID - DEVICE: Gelfilm (00300090297015)

GUDID

Device Identifier (DI) Information

Brand Name: Gelfilm
Version or Model: Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMACIA & UPJOHN COMPANY LLC

Primary DI Number: 00300090297015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618054084 *Terms of Use

Device Description: Anti-adhesion dressing, bioabsorbable

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HQX	IMPLANT, ORBITAL, EXTRA-OCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: See USP Controlled Room Temperature
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Millimeter
Device Size Text, specify: Thickness of film ranges from 0.060 to 0.175 mm
Width: 25 Millimeter

Device Record Status

Public Device Record Key: 7ec9b498-7330-4f1f-924b-7cda50e75fd7
Public Version Date: December 20, 2022
Public Version Number: 7
DI Record Publish Date: October 22, 2015