AccessGUDID - DEVICE: DermaQuik (00853909006365)

GUDID

Device Identifier (DI) Information

Brand Name: DermaQuik
Version or Model: Sport & Extreme Wound Closure Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 62552
Company Name: Dermaclip Us, L.L.C.

Primary DI Number: 00853909006365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 043924405 *Terms of Use

Device Description: DermaQuik Sport & Extreme Wound Closure Kit, OTC. Waterproof kit includes 2 Packages of DermaQuik Sport & Extreme Devices (1 Clip per Package, 1" Closure per Package), Enhanced Adhesive. Kit also includes 2 gauze pads, 2 alcohol swabs, 2 wound dressings. All products are packaged individually within the kit and are sterile.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 50 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 21 Millimeter

Device Record Status

Public Device Record Key: be2b4945-9109-4185-a0ad-934ebe0864b1
Public Version Date: May 01, 2023
Public Version Number: 1
DI Record Publish Date: April 21, 2023