Gelfilm

GUDID 00300090297039

Anti-adhesion dressing, bioabsorbable

PFIZER INC.

Surgical anti-adhesion dressing, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable
Primary Device ID00300090297039
NIH Device Record Key7ec9b498-7330-4f1f-924b-7cda50e75fd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelfilm
Version Model NumberGelfilm® Sterile Ophthalmic Film Ophthalmic film 6
Company DUNS829076566
Company NamePFIZER INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(484)865-6166
Emailkarena.arroyo@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com
Phone+1(484)865-6166
EmailUDICompliance@pfizer.com

Device Dimensions

Width25 Millimeter
Width25 Millimeter
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width25 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *See USP Controlled Room Temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100300090297015 [Primary]
GS100300090297039 [Package]
Contains: 00300090297015
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

HQXIMPLANT, ORBITAL, EXTRA-OCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-10
Device Publish Date2015-10-22

On-Brand Devices [Gelfilm]

00363539022067Anti-adhesion dressing, bioabsorbable
00363539020018Anti-adhesion dressing, bioabsorbable
00300090297039Anti-adhesion dressing, bioabsorbable
00300090283018Anti-adhesion dressing, bioabsorbable

Trademark Results [Gelfilm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GELFILM
GELFILM
97498810 not registered Live/Pending
Pfizer Inc.
2022-07-12
GELFILM
GELFILM
78585325 3144512 Live/Registered
Pharmacia & Upjohn Company LLC
2005-03-11
GELFILM
GELFILM
71610930 0561532 Live/Registered
UPJOHN COMPANY, THE
1951-03-06

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