FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOS Living
DI: 00057475560379
·
Model: 56037
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Living
- Primary DI
- 00057475560379
- Version / Model
- 56037
- Company Name
- Thermor Ltd
- Labeler DUNS
- 246883458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-31
- Public Version
- 1
- Public Version Date
- 2023-04-10
- Public Version Status
- New
- Public Device Record Key
- a3653ec7-cdc2-45a0-b44a-7fbc88f81133
Device Description
Crutch Tips
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| INP | Tips And Pads, Cane, Crutch And Walker | Physical Medicine | 890.3790 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15702 | Walking aid tip | A device designed as a formed piece of non-slip material (e.g., rubber or suitable plastic) that is attached to the ground-contacting end of a walking aid (e.g., a walking stick, crutch, or walking frame) to promote a secure purchase to the contact surface (ground or floor surfaces) thereby increasing the safety factor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10057475560376 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00057475560379 | GS1 |