DEVICE: Gelfilm (00300090297015)
Device Identifier (DI) Information
Gelfilm
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution
PFIZER INC.
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution
PFIZER INC.
Anti-adhesion dressing, bioabsorbable
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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
[?]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 |
---|
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
7ec9b498-7330-4f1f-924b-7cda50e75fd7
March 29, 2018
2
October 22, 2015
March 29, 2018
2
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
karena.arroyo@pfizer.com
karena.arroyo@pfizer.com