FRED'S TAMPONS

Primary DI
10084579122483
Brand
FRED'S TAMPONS
Company
FRED'S, INC.
Model
FR21806S0/2
Device description
SUPER SCENTED PLASTIC APPLICATOR TAMPONS
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HILTampon, Menstrual, Scented, Deodorized

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIL Tampon, Menstrual, Scented, Scented-DeodorizedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050067000FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFirst Quality Hygienic, Inc.2005-02-01HIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10084579122483PackageGS16In Commercial Distribution
00084579122486PrimaryGS10
00008457918848Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008457912248310084579122483
00084579122486000845791224860845791224860084579122486
00008457918848000084579188480084579188480008457918848

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, scentedA non-sterile plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. It is scented for aesthetic and deodorizing purposes to counter odorous smells resulting from the discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005866116
Device count
18
DM exempt
false
Premarket exempt
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084579122424FRED'S TAMPONS FR12006F/22016-09-13
00084579122431FRED'S TAMPONS FR22006F/22016-09-13
00084579122455FRED'S TAMPONS FR11806UO2016-09-13
00084579122462FRED'S TAMPONS FR21806UO/22016-09-13
00084579122479FRED'S TAMPONS FR11806SO2016-09-13
00084579122486FRED'S TAMPONS FR21806S0/22016-09-13
00084579123032FRED'S TAMPONS FR32006F/22016-09-13
10084579122421FRED'S TAMPONS FR12006F/22016-09-13
10084579122438FRED'S TAMPONS FR22006F/22016-09-13
10084579122452FRED'S TAMPONS FR11806UO2016-09-13
10084579122469FRED'S TAMPONS FR21806UO/22016-09-13
10084579122476FRED'S TAMPONS FR11806SO2016-09-13
10084579123039FRED'S TAMPONS FR32006F/22016-09-13
00761059407577Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00084579128570FRED'S SUPER DOLLAR2684962016-09-30
00084579128587FRED'S SUPER DOLLAR6371492016-09-30
00761059307570Fred's Unifine Pentips Plus - Short 8mmx31GAN 3830FRDAN 3830FRD2016-09-19
00761059842576Fred's Unifine Pentips Plus - Micro 4mmx32GAN 3840FRDAN 3840FRD2016-09-19
00761059507574Fred's Unifine Pentips Plus - Mini 5mmx31GAN 3850FRDAN 3850FRD2016-09-19
00084579118625Fred's Pharmacy118622016-09-16

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00073010632059TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
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40073010631630TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
40073010632125TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHIL2021-01-22
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10078300071126PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-04-01
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10078300098390PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2020-03-03
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00078300002178PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002185PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002192PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300002208PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300084792PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300089964PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
00078300098331PlaytexEDGEWELL PERSONAL CARE BRANDS, LLCHIL2019-04-01
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