FDA.reportPublic FDA data

Natracare

Primary DI
00782126001009
Brand
Natracare
Company
BODYWISE (UK) LIMITED
Model
Tampons Regular
Device description
Organic Cotton Tampon, Menstrual, Unscented Regular20 single use tampons per pack
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
K914430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914430000NATRACARE TAMPONBodywise (Uk), Ltd.1993-09-03HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019493010002PackageGS112In Commercial Distribution
00782126001009PrimaryGS10
00782126001001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05019493010002050194930100025019493010002
00782126001009007821260010097821260010090782126001009
00782126001001007821260010017821260010010782126001001

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA 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.

Contacts#

Phone, Email table
PhoneEmail
855 265 9289infona@natracare.com

Regulatory Flags#

DUNS number
503650061
Device count
20
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00782126002006NatracareTampons Super2016-09-22
00782126002020NatracareTampons Super Plus2016-09-22
00782126008008NatracareTampons with Applicator Regular2016-09-22
00782126009005NatracareTampons with Applicator Super2016-09-22
00782126181039NatracareTampons Regular2016-09-22
00782126191038NatracareTampons Super2016-09-22
05019493010002NatracareTampons Regular 2016-09-22
05019493020001NatracareTampons Super2016-09-22
05019493020025NatracareTampons Super Plus2016-09-22
05019493080029NatracareTampons with Applicator Regular2016-09-22
05019493090028NatracareTampons with Applicator Super2016-09-22
05019493081033NatracareTampons Regular2016-09-22
05019493091032NatracareTampons Super2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00073010721517This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721524This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721616This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721623This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721685TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721807TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721845TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721906TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721968TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00195893628032Organic Light Tampons-8ctTPC Inc.HEB2026-05-28
00195893724130Organic Super Tampons-8ctTPC Inc.HEB2026-05-28
00195893932832Organic Regular Tampons-8ctTPC Inc.HEB2026-05-28
00196852297061Organic Light Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852637379Organic Super Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852929245Organic Regular Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00860010723173Organic Regular Tampons-550ctTPC Inc.HEB2026-05-28
00860012610303Organic Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860012610310Organic Regular Tampons-16ctTPC Inc.HEB2026-05-28
00860013110925Organic Super Tampons-16ctTPC Inc.HEB2026-05-28
00860013110932Organic Light Tampons-16ctTPC Inc.HEB2026-05-28
00860013110956Organic Light Tampons-24ctTPC Inc.HEB2026-05-28
00860013110963Organic Super Tampons-24ctTPC Inc.HEB2026-05-28