FDA.report

Tampax

Primary DI
10073010715377
Brand
Tampax
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
Tampax Cup
Device description
Tampax Cup Heavy 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
10073010715315PackageGS16In Commercial Distribution
10073010715377PackageGS112In Commercial Distribution
20073010715312PackageGS13In Commercial Distribution
40073010715316PackageGS1112In Commercial Distribution
40073010715378PackageGS148In Commercial Distribution
00073010715318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1007301071531510073010715315
1007301071537710073010715377
2007301071531220073010715312
4007301071531640073010715316
4007301071537840073010715378
00073010715318000730107153180730107153180073010715318

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

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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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