FDA.report

Trulife

Primary DI
00645517377643
Brand
Trulife
Company
TRULIFE LIMITED
Model
SEC202-27R
Device description
COSMETIC COVER 27-R TALL
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ISHCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Product Code Classifications

CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00645517377643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517377643006455173776436455173776430645517377643

GMDN Terms

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

Regulatory Flags

DUNS number
289728891
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517872773TrulifeSSF400-27-L-2 2025-09-19
00645517872780TrulifeSSF400-27-L-3 2025-09-19
00645517872827TrulifeSSF400-28-L-1 2025-09-19
00645517872834TrulifeSSF400-28-L-2 2025-09-19
00645517872872TrulifeSSF400-28-R-3 2025-09-19
00645517872889TrulifeSSF400-29-L-2 2025-09-19
00645517872933TrulifeSSF400-30-R-3 2025-09-19
00645517872988TrulifeSSF403-23-R-1 2025-09-19
00645517873039TrulifeSSF403-24-R-1 2025-09-19
00645517873084TrulifeSSF403-25-L-3 2025-09-19
00645517873138TrulifeSSF403-26-L-2 2025-09-19
00645517873183TrulifeSSF403-27-L-1 2025-09-19
00645517873190TrulifeSSF403-27-L-2 2025-09-19
00645517873237TrulifeSSF403-27-R-3 2025-09-19
00645517873244TrulifeSSF403-28-L-1 2025-09-19
00645517873282TrulifeSSF403-28-R-2 2025-09-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00645517872773TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872780TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872827TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872834TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872872TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872889TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872933TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872988TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873039TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873084TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873138TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873183TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873190TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873237TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873244TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873282TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873299TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873305TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873336TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873343TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873350TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896175TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896182TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896199TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896205TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896212TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896229TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896236TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896243TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896250TrulifeTRULIFE LIMITEDISH2025-09-19