Gelfoam
GUDID 00300090396053
Absorbable Hemostatic Sponge, Collagen Based
PHARMACIA & UPJOHN COMPANY LLC
Collagen haemostatic agent, non-antimicrobial| Primary Device ID | 00300090396053 |
| NIH Device Record Key | 7f5bed05-7c19-4044-81b6-ce1fbe5a2fb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelfoam |
| Version Model Number | Size 4, 2 sponges per envelope |
| Company DUNS | 618054084 |
| Company Name | PHARMACIA & UPJOHN COMPANY LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 |
| 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 | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Height | 7 Millimeter |
Operating and Storage Conditions
| 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 | 00300090396053 [Package] Contains: 10300090396050 Package: Carton [6 Units] In Commercial Distribution |
| GS1 | 10300090396050 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N18286
FDA Product Code
| LMF | Agent, absorbable hemostatic, collagen based |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-12-17 |
| Device Publish Date | 2014-09-01 |
On-Brand Devices [Gelfoam]
| 00300090433048 | Absorbable Hemostatic Powder, Collagen Based |
| 00300090396053 | Absorbable Hemostatic Sponge, Collagen Based |
| 00300090353018 | Absorbable Hemostatic Sponge, Collagen Based |
| 00300090349035 | Absorbable Hemostatic Sponge, Collagen Based |
| 00300090342012 | Absorbable Hemostatic Sponge, Collagen Based |
| 00300090323011 | Absorbable Hemostatic Sponge, Collagen Based |
| 00300090315085 | Absorbable Hemostatic Sponge, Collagen Based |
Trademark Results [Gelfoam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELFOAM 87563882 not registered Dead/Abandoned |
Pharmacia & Upjohn Company LLC 2017-08-10 |
 GELFOAM 87256676 not registered Live/Pending |
Pharmacia & Upjohn Company LLC 2016-12-05 |
 GELFOAM 87159942 5466464 Live/Registered |
Brown Innovation, LLC 2016-09-02 |
 GELFOAM 85779149 not registered Dead/Abandoned |
Pharmacia & Upjohn Company LLC 2012-11-14 |
 GELFOAM 85083368 not registered Dead/Abandoned |
L.P.I. Consumer Products, Inc. 2010-07-13 |
 GELFOAM 78653231 not registered Dead/Abandoned |
Power Products, Inc. 2005-06-17 |
 GELFOAM 78585318 3167548 Live/Registered |
Pharmacia & Upjohn Company LLC 2005-03-11 |
 GELFOAM 74152375 not registered Dead/Abandoned |
APLUS DESIGN & MANUFACTURING CORP. 1991-03-29 |
 GELFOAM 71489625 0429268 Live/Registered |
UPJOHN COMPANY, THE 1945-10-08 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.