AccessGUDID - DEVICE: U by Kotex (00036000150636)

GUDID

Device Identifier (DI) Information

Brand Name: U by Kotex
Version or Model: Tampon
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KIMBERLY-CLARK GLOBAL SALES, INC.

Primary DI Number: 00036000150636
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2021
Device Count: 18
Labeler D-U-N-S® Number*: 829568273 *Terms of Use

Device Description: U BY KOTEX PREMIUM SECURITY REGULAR ABSORBENCY TAMPONS

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):	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?
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEB	TAMPON, MENSTRUAL, UNSCENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141294	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
Weight: 9 Gram

Device Record Status

Public Device Record Key: 187f0c85-4085-42d6-b1c7-78cbee58fe38
Public Version Date: June 10, 2022
Public Version Number: 8
DI Record Publish Date: September 23, 2016