AccessGUDID - DEVICE: Seventh Generation (00732913451098)

GUDID

Device Identifier (DI) Information

Brand Name: Seventh Generation
Version or Model: Super, with plant-based plastic applicator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45109
Company Name: SEVENTH GENERATION, INC.

Primary DI Number: 00732913451098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 178161212 *Terms of Use

Device Description: Organic Cotton Comfort Applicator Tampons, Super (plant-based plastic applicator)

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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 492b63ee-7c5f-486e-af5b-7d22ce5d3543
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: April 17, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10732913451095	12	00732913451098	2020-06-30	Not in Commercial Distribution	Case
50732913446433	2	00732913451098	2020-06-30	Not in Commercial Distribution	Box
10732913446435	6	50732913446433	2020-06-30	Not in Commercial Distribution	Case
10732913447852	6	00732913451098		In Commercial Distribution	Case