AccessGUDID - DEVICE: Well at Walgreens (00049022632837)

GUDID

Device Identifier (DI) Information

Brand Name: Well at Walgreens
Version or Model: 411505
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 170265
Company Name: WALGREEN CO.

Primary DI Number: 00049022632837
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2016
Device Count: 36
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: Plastic Applicator Tampon, Super absorbency 36

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Menstrual tampon, unscented	A non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
HEB	Tampon, Menstrual, Unscented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020535	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
Device Size Text, specify: Absorbency

Device Record Status

Public Device Record Key: d5ed58b7-9f28-4944-88d1-b2598d7cf928
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 16, 2016