AccessGUDID - DEVICE: exofin HVTSA Premier Pro, 1g (00854137001672)

GUDID

Device Identifier (DI) Information

Brand Name: exofin HVTSA Premier Pro, 1g
Version or Model: 3470
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3470
Company Name: Chemence Medical, Inc.

Primary DI Number: 00854137001672
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079163089 *Terms of Use

Device Description: Premier Pro High Viscosity Tissue Adhesive 1.0g

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

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 [?]
K152476	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7f62b26-8253-4db4-9c31-847fd7dccf6a
Public Version Date: August 15, 2024
Public Version Number: 3
DI Record Publish Date: November 08, 2021