SURGIFLO® Hemostatic Matrix Kit with Thrombin

GUDID 15712123000325

Ferrosan Medical Devices A/S

Gelatin haemostatic agent Gelatin haemostatic agent
Primary Device ID15712123000325
NIH Device Record Key963cec92-60d4-4dfd-99ae-8216d5262e64
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSURGIFLO® Hemostatic Matrix Kit with Thrombin
Version Model Number2993
Company DUNS305175344
Company NameFerrosan Medical Devices A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115712123000325 [Primary]
GS125712123000322 [Package]
Package: Box [6 Units]
Discontinued: 2017-11-30
Not 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-08
Device Publish Date2014-09-20

On-Brand Devices [SURGIFLO® Hemostatic Matrix Kit with Thrombin]

157121230003252993
157121230002882994

Trademark Results [SURGIFLO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGIFLO
SURGIFLO
85129993 4088736 Live/Registered
JOHNSON & JOHNSON
2010-09-15
SURGIFLO
SURGIFLO
76480019 3015900 Live/Registered
JOHNSON & JOHNSON
2002-12-30

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