AccessGUDID - DEVICE: Diva Underwear (00841445000435)

GUDID

Device Identifier (DI) Information

Brand Name: Diva Underwear
Version or Model: M-L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGUN060101BK02
Company Name: Diva International Inc

Primary DI Number: 00841445000435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207651758 *Terms of Use

Device Description: Diva Period Underwear - EO (Each) - Bikini Black M-L

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
66318	Menstrual underwear	A garment intended to be worn directly against the skin, in the same manner as conventional women's underwear, to absorb menstrual blood or other vaginal discharge. It is typically constructed of cotton, lycra and/or polyester with a leak-proof thermoplastic polyurethane (TPU) barrier. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUQ	Pad, Menstrual, Reusable

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: 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: 963b4183-bd6f-4471-9033-744b0987cd94
Public Version Date: August 01, 2025
Public Version Number: 3
DI Record Publish Date: July 17, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10841445000364	6	00841445000435		In Commercial Distribution	Case Pack
20841445000330	24	10841445000364		In Commercial Distribution	Master Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18664443482
Email: qaregulatory@divacup.com

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