Trulife

Basic Information

• Brand Name: Trulife
• Primary DI: 00645517318332
• Version / Model: RSC100-ST-3
• Company Name: TRULIFE LIMITED
• Labeler DUNS: 289728891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-31
• Public Version: 2
• Public Version Date: 2023-06-07
• Public Version Status: Update
• Public Device Record Key: 0758f9fc-4d03-422e-a244-4a2f78faa33c

Device Description

CASH FIX STRN/PUB STD BACKPAD 42

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQF	ORTHOSIS, CERVICAL-THORACIC, RIGID	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58757	Spine thermoplastic splint system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00645517318332	GS1