DEVICE: Gelfilm (00300090297015)

Device Identifier (DI) Information

Gelfilm
GelfilmĀ® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution

PFIZER INC.
00300090297015
GS1

1
829076566 *Terms of Use
Anti-adhesion dressing, bioabsorbable
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: Ā© 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.
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FDA Product Code

[?]
Product Code Product Code Name
HQX IMPLANT, ORBITAL, EXTRA-OCULAR
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: See USP Controlled Room Temperature
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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
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Device Record Status

7ec9b498-7330-4f1f-924b-7cda50e75fd7
March 29, 2018
2
October 22, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(484)865-6166
karena.arroyo@pfizer.com
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