GEL-FLOW™ NT
GUDID 00300091040061
Absorbable Hemostatic Sponge, Collagen Based
PFIZER INC.
General/plastic surgical procedure kit, non-medicated, single-use| Primary Device ID | 00300091040061 |
| NIH Device Record Key | 36f2b5f7-f981-4e57-aaa1-3ae2b5af97b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEL-FLOW™ NT |
| Version Model Number | Hemostatic Matrix for Flowable Applications - 6 mL |
| Company DUNS | 829076566 |
| Company Name | PFIZER INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arrenon@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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00300091040016 [Primary] |
| GS1 | 00300091040061 [Package] Contains: 00300091040016 Package: Carton [6 Units] In Commercial Distribution |
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 | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-17 |
Devices Manufactured by PFIZER INC.
| 05415062388310 - wtATTR-CM AcceleraTTR™ | 2022-08-08 Software to identify heart failure patients who may be at risk of having wtATTR-CM |
| 00305733010020 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP S/M 8HR 2CT |
| 00305733010037 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 2CT |
| 00305733010075 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010389 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010396 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010969 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010983 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP 8CT + NECK/SHOULDER/WRIST 1CT |
Trademark Results [GEL-FLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEL-FLOW 87558617 5542428 Live/Registered |
Pharmacia & Upjohn Company LLC 2017-08-07 |
 GEL-FLOW 87540062 5542389 Live/Registered |
Pharmacia & Upjohn Company LLC 2017-07-24 |
 GEL-FLOW 85173387 4068480 Live/Registered |
PPG ARCHITECTURAL FINISHES, INC. 2010-11-10 |
 GEL-FLOW 74691688 not registered Dead/Abandoned |
DR FABRICANT'S FOOT HEALTH PRODUCTS, INC. 1995-06-21 |
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