Trulife

Primary DI
00645517377551
Brand
Trulife
Company
TRULIFE LIMITED
Model
SEC201-24L
Device description
COSMETIC COVER 24-L SHORT
Published
2022-12-31
Public version status
Update
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
ISHCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00645517377551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517377551006455173775516455173775510645517377551

GMDN Terms#

Term, Definition table
TermDefinition
External limb prosthesis finishing component, non-customizedA prefabricated cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) ready to be assembled, fitted, and adjusted to the patient. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
289728891
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

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