Gelfilm
GUDID 00300090297039
Anti-adhesion dressing, bioabsorbable
PFIZER INC.
Surgical anti-adhesion dressing, implantable, bioabsorbable| Primary Device ID | 00300090297039 |
| NIH Device Record Key | 7ec9b498-7330-4f1f-924b-7cda50e75fd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelfilm |
| Version Model Number | Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6 |
| Company DUNS | 829076566 |
| Company Name | PFIZER INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com |
Device Dimensions
| Width | 25 Millimeter |
| Width | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
| Length | 50 Millimeter |
| Device Size Text, specify | 0 |
| Width | 25 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00300090297015 [Primary] |
| GS1 | 00300090297039 [Package] Contains: 00300090297015 Package: Carton [6 Units] In Commercial Distribution |
FDA Product Code
| HQX | IMPLANT, ORBITAL, EXTRA-OCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2015-10-22 |
On-Brand Devices [Gelfilm]
| 00363539022067 | Anti-adhesion dressing, bioabsorbable |
| 00363539020018 | Anti-adhesion dressing, bioabsorbable |
| 00300090297039 | Anti-adhesion dressing, bioabsorbable |
| 00300090283018 | Anti-adhesion dressing, bioabsorbable |
Trademark Results [Gelfilm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELFILM 97498810 not registered Live/Pending |
Pfizer Inc. 2022-07-12 |
 GELFILM 78585325 3144512 Live/Registered |
Pharmacia & Upjohn Company LLC 2005-03-11 |
 GELFILM 71610930 0561532 Live/Registered |
UPJOHN COMPANY, THE 1951-03-06 |
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