AccessGUDID - DEVICE: TissuGlu Surgical Adhesive (M690TG100US0)

GUDID

Device Identifier (DI) Information

Brand Name: TissuGlu Surgical Adhesive
Version or Model: TG100US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TG100US
Company Name: COHERA MEDICAL, INC.

Primary DI Number: M690TG100US0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145195199 *Terms of Use

Device Description: TissuGlu Surgical Adhesive

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58777	Surgical internal adhesive/sealant, synthetic polymer	A biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PJK	Tissue Adhesive For Internal Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at Room Temperature 25C
Storage Environment Temperature: less than 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4107c303-e8ab-49ab-a166-cb56071ffc75
Public Version Date: February 21, 2022
Public Version Number: 4
DI Record Publish Date: February 13, 2017