SURGICEL FIBRILLAR 411961

GUDID 20705031005195

Surgicel Fibrillar Absorbable Hemostat

ETHICON, LLC

Plant polysaccharide haemostatic agent, bioabsorbable
Primary Device ID20705031005195
NIH Device Record Key3dde0b34-a9dd-4620-ab69-4e0d7d25c085
Commercial Distribution Discontinuation2020-05-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSURGICEL FIBRILLAR
Version Model Number411961
Catalog Number411961
Company DUNS829465157
Company NameETHICON, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031005198 [Primary]
GS120705031005195 [Package]
Contains: 10705031005198
Package: CASE [10 Units]
Discontinued: 2020-05-05
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMGAgent, absorbable hemostatic, non-collagen based

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number9
Public Version Date2020-05-05
Device Publish Date2014-09-20

On-Brand Devices [SURGICEL FIBRILLAR]

20705031005218Surgicel Fibrillar Absorbable Hemostat
20705031005201Surgicel Fibrillar Absorbable Hemostat
20705031005195Surgicel Fibrillar Absorbable Hemostat
20705031005355Surgicel Fibrillar Absorbable Hemostat
20705031005362Surgicel Fibrillar Absorbable Hemostat

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