GEL-FLOW™ NT

GUDID 00300091040061

Absorbable Hemostatic Sponge, Collagen Based

PFIZER INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use
Primary Device ID00300091040061
NIH Device Record Key36f2b5f7-f981-4e57-aaa1-3ae2b5af97b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEL-FLOW™ NT
Version Model NumberHemostatic Matrix for Flowable Applications - 6 mL
Company DUNS829076566
Company NamePFIZER INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@pfizer.com
Phone+1(484)865-6166
Emailkarena.arrenon@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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100300091040016 [Primary]
GS100300091040061 [Package]
Contains: 00300091040016
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMFAgent, absorbable hemostatic, collagen based

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-17

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00305733010396 - ThermaCare HeatWraps2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT
00305733010969 - ThermaCare HeatWraps2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT
00305733010983 - ThermaCare HeatWraps2020-06-08 THERMACARE LOWER BACK & HIP 8CT + NECK/SHOULDER/WRIST 1CT

Trademark Results [GEL-FLOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GEL-FLOW
GEL-FLOW
87558617 5542428 Live/Registered
Pharmacia & Upjohn Company LLC
2017-08-07
GEL-FLOW
GEL-FLOW
87540062 5542389 Live/Registered
Pharmacia & Upjohn Company LLC
2017-07-24
GEL-FLOW
GEL-FLOW
85173387 4068480 Live/Registered
PPG ARCHITECTURAL FINISHES, INC.
2010-11-10
GEL-FLOW
GEL-FLOW
74691688 not registered Dead/Abandoned
DR FABRICANT'S FOOT HEALTH PRODUCTS, INC.
1995-06-21

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