FDA.reportPublic FDA data

Trulife

Primary DI
00645517110042
Brand
Trulife
Company
Trulife Limited
Model
B190A38
Device description
IRENE BLACK CLASSIC FULL SUPPORT SOFT CUP MASTECTOMY BRA B190A38
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
NOKMATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOKMaterial, External Aesthetic Restoration, No AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00645517110042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517110042006455171100426455171100420645517110042

GMDN Terms#

Term, Definition table
TermDefinition
Postsurgical brassiere, non-antimicrobialA woman's undergarment designed to support and/or contour the breast(s) after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); it may also be intended for use during medical treatment (e.g., chemotherapy). It may also be referred to as bra, and is specifically designed for patient support/comfort in the home or healthcare facility; it does not include antimicrobial features. 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
00645517110028TrulifeTrulife LimitedNOK2022-12-31
00645517110035TrulifeTrulife LimitedNOK2022-12-31
00645517110066TrulifeTrulife LimitedNOK2022-12-31
00645517110073TrulifeTrulife LimitedNOK2022-12-31
00645517110080TrulifeTrulife LimitedNOK2022-12-31
00645517110097TrulifeTrulife LimitedNOK2022-12-31
00645517110103TrulifeTrulife LimitedNOK2022-12-31
00645517110127TrulifeTrulife LimitedNOK2022-12-31
00645517110134TrulifeTrulife LimitedNOK2022-12-31
00645517110141TrulifeTrulife LimitedNOK2022-12-31
00645517110158TrulifeTrulife LimitedNOK2022-12-31
00645517110165TrulifeTrulife LimitedNOK2022-12-31
00645517110172TrulifeTrulife LimitedNOK2022-12-31
00645517110189TrulifeTrulife LimitedNOK2022-12-31
00645517110202TrulifeTrulife LimitedNOK2022-12-31
00645517110219TrulifeTrulife LimitedNOK2022-12-31
00645517110226TrulifeTrulife LimitedNOK2022-12-31
00645517110233TrulifeTrulife LimitedNOK2022-12-31
00645517110240TrulifeTrulife LimitedNOK2022-12-31
00645517110257TrulifeTrulife LimitedNOK2022-12-31
00645517110264TrulifeTrulife LimitedNOK2022-12-31
00645517110271TrulifeTrulife LimitedNOK2022-12-31
00645517110288TrulifeTrulife LimitedNOK2022-12-31
00645517110295TrulifeTrulife LimitedNOK2022-12-31
00645517110301TrulifeTrulife LimitedNOK2022-12-31
00645517110318TrulifeTrulife LimitedNOK2022-12-31
00645517110325TrulifeTrulife LimitedNOK2022-12-31
00645517112848TrulifeTrulife LimitedNOK2022-12-31
00645517112855TrulifeTrulife LimitedNOK2022-12-31
00645517112862TrulifeTrulife LimitedNOK2022-12-31