AccessGUDID - DEVICE: microMend (00850018777018)

GUDID

Device Identifier (DI) Information

Brand Name: microMend
Version or Model: M1S2K001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M1S2K001
Company Name: Kitotech Medical Inc

Primary DI Number: 00850018777018
Issuing Agency: GS1
Commercial Distribution End Date: September 23, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 007908602 *Terms of Use

Device Description: Emergency Laceration Kit: 2 – microMend Closures 1/2 IN x 1 IN (12 mm x 28 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 178 mm); 2 – Gauze Packages 2 IN x 2 IN (51 mm x 51 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:	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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

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: d628d694-b519-4d52-ab96-0ded5065e7a2
Public Version Date: May 17, 2024
Public Version Number: 3
DI Record Publish Date: December 08, 2022