FDA.reportPublic FDA data

Playtex

Primary DI
10078300082559
Brand
Playtex
Company
EDGEWELL PERSONAL CARE BRANDS, LLC
Model
08255
Device description
SPORT 32 CT ODOR SHIELD SUPER 4/3
Published
2020-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HEBTampon, menstrual, unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111684000PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDPlaytex Manufacturing, Inc.2012-02-03HIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10078300082559PackageGS14In Commercial Distribution
20078300082556PackageGS13In Commercial Distribution
00078300082552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007830008255910078300082559
2007830008255620078300082556
00078300082552000783000825520783000825520078300082552

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151179769
Device count
1
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
false
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
00078300147961Playtex147962025-07-07
00078300147978Playtex147962025-07-07
00078300081098Playtex081092019-04-01
00078300021797OB021792024-03-25
00078300070108OB070102020-04-01
10078300147968Playtex147962025-07-07
10078300147975Playtex147962025-07-07
00078300070245Stayfree070242019-04-30
00078300099239Playtex099232019-04-01
00078300081111Playtex081112019-04-01
00078300070115OB070112019-04-01
00078300081364Playtex081362019-04-01
10078300021794OB021792024-03-25
00078300141082Playtex141082024-03-22
00078300141099Playtex141082024-03-22
10078300141089Playtex141082024-03-22
10078300141096Playtex141082024-03-22
00078300081357Playtex081352019-04-01
00078300099277Playtex099272019-04-01
00078300089971Playtex089972019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086435407With The FlowWith The Flow LLCHEB2026-11-04
00810042482944CoraCoraHEB2026-10-29
06972465050002Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050309Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050323Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
06972465050361Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
05060994741759DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741766DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741773DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741780DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
08806011638117Dong-A Pharmaceutical Co., Ltd.Dong-A Pharmaceutical Co., Ltd.HEB2026-09-29
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00073010720091TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010720831TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721173TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721210This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721227TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721272TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721333This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721340TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25