TissuGlu Surgical Adhesive TG100US

GUDID M690TG100US0

TissuGlu Surgical Adhesive

COHERA MEDICAL, INC.

Surgical internal adhesive/sealant, synthetic polymer
Primary Device IDM690TG100US0
NIH Device Record Key4107c303-e8ab-49ab-a166-cb56071ffc75
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissuGlu Surgical Adhesive
Version Model NumberTG100US
Catalog NumberTG100US
Company DUNS145195199
Company NameCOHERA MEDICAL, INC.
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(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com
Phone(800) 641-7458
Emailcs@coheramed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature 25C
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM690TG100US0 [Primary]
HIBCCM690TG100US3 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJKTissue Adhesive For Internal Use

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


[M690TG100US0]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-21
Device Publish Date2017-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.