FDA.report

Trulife

Primary DI
00645517318318
Brand
Trulife
Company
TRULIFE LIMITED
Model
RSC100-ST-1
Device description
CASH FIX STERN/PUB STD BACKPAD 30
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
IQFORTHOSIS, CERVICAL-THORACIC, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
IQFOrthosis, Cervical-Thoracic, RigidPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00645517318318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517318318006455173183186455173183180645517318318

GMDN Terms

TermDefinition
Spine thermoplastic splint systemAn assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

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
00645517888613TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517890883TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517898940TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517899114TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517024189TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323831TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323848TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323886TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323947TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510729TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510743TrulifeTRULIFE LIMITEDIQF2025-09-03
08057592700094NECKLITEFLAMOR SRLIQF2025-01-27
08057592700100NECKLITEFLAMOR SRLIQF2025-01-27
08057592700117NECKLITEFLAMOR SRLIQF2025-01-27
08057592700124NECKLITEFLAMOR SRLIQF2025-01-27
08057592700131NECKLITEFLAMOR SRLIQF2025-01-27
08057592700148NECKLITEFLAMOR SRLIQF2025-01-27
00645517024172TrulifeTRULIFE LIMITEDIQF2023-06-06
00645517322674TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322681TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322698TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517325002TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326306TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326351TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326375TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517317991TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318004TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318011TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318028TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318035TrulifeTRULIFE LIMITEDIQF2022-12-31