FDA.reportPublic FDA data

Trulife

Primary DI
00645517725666
Brand
Trulife
Company
Trulife Limited
Model
630JD12
Device description
JODEE 46-12 ACTIVEFLOW BREAST FORM
Published
2022-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00645517725666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517725666006455177256666455177256660645517725666

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.

Regulatory Flags#

DUNS number
201789518
Device count
1
Premarket exempt
true
Lot or batch
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
00643293000113A 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