FDA.report

Tampax

Primary DI
10073010715360
Brand
Tampax
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
Tampax Cup
Device description
Tampax Cup Regular Flow
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HHECup, menstrual

Product Code Classifications

CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10073010715308PackageGS16In Commercial Distribution
10073010715360PackageGS112In Commercial Distribution
20073010715305PackageGS13In Commercial Distribution
40073010715309PackageGS1112In Commercial Distribution
40073010715361PackageGS148In Commercial Distribution
00073010715301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1007301071530810073010715308
1007301071536010073010715360
2007301071530520073010715305
4007301071530940073010715309
4007301071536140073010715361
00073010715301000730107153010730107153010073010715301

GMDN Terms

TermDefinition
Menstrual cup, non-latex, reusableA cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
004238200
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10047400703237Braun Silk.expert Pro 5PL54422026-01-05
10047400703367Braun Skin i-expertPL72192026-01-05
40073010720747TampaxTampax Pearl2025-12-19
20073010720750TampaxTampax Pearl2025-12-19
10073010721040TampaxTampax Pearl2025-12-19
40073010721058TampaxTampax Pearl2025-12-19
40073010721263TampaxTampax Pearl2025-12-19
10073010721316L.This is L. Tampon2025-12-19
10073010721323L.This is L. Tampon2025-12-19
40073010720440TampaxTampax Radiant2025-06-23
40073010720822TampaxTampax Radiant2025-06-23
40073010720921TampaxL. Tampon2025-06-23
20073010719440L.This is L.2025-04-29
10073010719467L.This is L.2025-04-29
40073010719482L.This is L.2025-04-29
10073010719740TampaxTampax Pearl2025-04-29
20073010719761L.This is L.2025-04-29
10073010719771L.This is L.2025-04-29
10073010719788L.This is L.2025-04-29

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