DEVICE: Gelfilm (00300090297015)
Device Identifier (DI) Information
Gelfilm
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution
PHARMACIA & UPJOHN COMPANY LLC
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution
PHARMACIA & UPJOHN COMPANY LLC
Anti-adhesion dressing, bioabsorbable
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
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
7ec9b498-7330-4f1f-924b-7cda50e75fd7
December 20, 2022
7
October 22, 2015
December 20, 2022
7
October 22, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00300090297039 | 6 | 00300090297015 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(484)865-6166
UDICompliance@pfizer.com
UDICompliance@pfizer.com