AccessGUDID - DEVICE: TissueLink (00009336010042)

GUDID

Device Identifier (DI) Information

Brand Name: TissueLink
Version or Model: 32031775
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 32031775
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336010042
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: TissueLink - Flex

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?
34164	Skin-approximation adhesive	A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.	Active	false
58779	Dermal surgical adhesive/sealant applicator	A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPN	Tissue Adhesive For The Topical Approximation Of Skin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage Environment Temperature: less than 72 degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: .5 Milliliter

Device Record Status

Public Device Record Key: aec50097-2834-48b0-90fa-ccf07d62be85
Public Version Date: December 09, 2022
Public Version Number: 2
DI Record Publish Date: January 08, 2021