FDA.reportPublic FDA data

A Supreme

Primary DI
00643293000113
Brand
A Supreme
Company
TRULIFE LIMITED
Model
503 6L
Device description
A Supreme Left Size 6
Published
2022-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NOJPROSTHESIS, BREAST, EXTERNAL, NO ADHESIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOJProsthesis, Breast, External, No AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643293000113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643293000113006432930001136432930001130643293000113

GMDN Terms#

Term, Definition table
TermDefinition
External breast prosthesisAn external device intended to replace the female breast typically after a mastectomy. It is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere.

Regulatory Flags#

DUNS number
985048669
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00645517899312TrulifeTN200-22026-04-22
00645517899329TrulifeTN200-32026-04-22
00645517899336TrulifeTN200-42026-04-22
00645517899343TrulifeTN200-52026-04-22
00645517899398TrulifeTN200-KIT2026-04-22
00645517899404TrulifeTN250-KIT2026-04-22
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517024189Trulife08005042025-09-03
00645517323831TrulifeO109012025-09-03
00645517323848TrulifeO109022025-09-03
00645517323886TrulifeO109312025-09-03
00645517323947TrulifeO113942025-09-03
00645517510729TrulifeO109272025-09-03
00645517510743TrulifeO109282025-09-03
00645517024172Trulife08005022023-06-06
00645517325002TrulifeA378022022-12-31
00645517324104Trulife1400027R002022-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643293000014A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000021A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000038A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000045A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000052A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000069A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000076A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000083A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000090A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000106A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000120A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000137A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000144A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000151A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000168A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000175A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000182A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000199A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000205A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000212A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000229A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000236A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000243A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000250A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000267A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000274A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000281A SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000298E SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000304E SupremeTRULIFE LIMITEDNOJ2022-12-31
00643293000311E SupremeTRULIFE LIMITEDNOJ2022-12-31