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: PFIZER INC.

Primary DI Number: 00300090297015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829076566 *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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Anti-adhesion dressing, bioabsorbable	A sterile bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal or pelvic surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a modified cellulose material.

FDA Product Code

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

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: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 22, 2015