AccessGUDID - DEVICE: Exofin Fusion Skin Closure System (00854137001238)

GUDID

Device Identifier (DI) Information

Brand Name: Exofin Fusion Skin Closure System
Version or Model: 22cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EF70401
Company Name: Chemence Medical, Inc.

Primary DI Number: 00854137001238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079163089 *Terms of Use

Device Description: Cutaneous Tissue Adhesive With Mesh

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?
46880	Wound closure set, topical	A collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMD	Cutaneous Tissue Adhesive With Mesh

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171442	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: dca894a2-eaf8-43d3-81dd-c118fbf44182
Public Version Date: August 15, 2024
Public Version Number: 4
DI Record Publish Date: October 25, 2017