FDA UDI
In Commercial Distribution
🇺🇸 United States
Trulife
DI: 00645517323886
·
Model: O10931
·
TRULIFE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Trulife
- Primary DI
- 00645517323886
- Version / Model
- O10931
- Company Name
- TRULIFE LIMITED
- Labeler DUNS
- 289728891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-03
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 772cb745-f433-400f-95b7-d5aa67fb64a2
Device Description
PAD CHIN SM MINERVA
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 |
|---|---|---|---|---|
| 45258 | Extrication collar, reusable | A rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00645517323886 | GS1 |