FDA.reportPublic FDA data

Trulife

Primary DI
00645517556260
Brand
Trulife
Company
TRULIFE LIMITED
Model
GS101R
Device description
GUNSLINGER II BRACE RT BLACK
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
MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00645517556260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517556260006455175562606455175562600645517556260

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, single-useA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a single-use device.

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00645517890821TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892757TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892764TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517898766TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899077TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899121TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
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00819567017846ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003107ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003114ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003480ComfytopiaComfytopia, Inc.MRI2025-07-09
00810178881567CoreTechVIVE HEALTH LLCMRI2025-05-19
10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19