AccessGUDID - DEVICE: Dong-A Pharmaceutical Co., Ltd. (08806011632863)

GUDID

Device Identifier (DI) Information

Brand Name: Dong-A Pharmaceutical Co., Ltd.
Version or Model: Tempo Tampon Regular
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dong-A Pharmaceutical Co., Ltd.

Primary DI Number: 08806011632863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688733015 *Terms of Use

Device Description: The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

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):	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?
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: 11d40e5e-466b-4d7f-8875-fb3029bba451
Public Version Date: April 08, 2024
Public Version Number: 2
DI Record Publish Date: February 14, 2023