AccessGUDID - DEVICE: microMend (00850018777025)

GUDID

Device Identifier (DI) Information

Brand Name: microMend
Version or Model: M3S2D001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M3S2D001
Company Name: Kitotech Medical Inc

Primary DI Number: 00850018777025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 007908602 *Terms of Use

Device Description: Emergency Laceration Closures (Qty. 6), MULTI: 3 Packs of 2 MEDIUM 1/2 IN x 1 IN (12 mm x 28 mm)

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:	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?
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
GDT	Staple, Removable (Skin)
KGX	Tape And Bandage, Adhesive

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 16 and 26 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45026c11-9127-41d9-887d-4afc4ba334f3
Public Version Date: May 17, 2024
Public Version Number: 2
DI Record Publish Date: December 08, 2022