BIOS Living
- Primary DI
- 10057475210424
- Brand
- BIOS Living
- Company
- Thermor Ltd
- Model
- LK042
- Device description
- Adjustable Elbow Support Brace
- Published
- 2023-03-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| IOY | Support, Arm |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IOY | Support, Arm | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10057475210424 | Package | GS1 | 6 | In Commercial Distribution |
| 00057475210427 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10057475210424 | 10057475210424 | ||
| 00057475210427 | 00057475210427 | 057475210427 | 0057475210427 |
GMDN Terms
| Term | Definition |
|---|---|
| Elbow orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 246883458
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- 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 DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 20057475032504 | BIOS Diagnostics | W250 | 2026-01-19 | |
| 00057475242909 | BIOS Diagnostics | BD290 | 2026-01-19 | |
| 10057475491502 | BIOS Diagnostics | NS150 | 2026-01-19 | |
| 00057475820213 | BIOS Living | RL021 | 2026-01-19 | |
| 20057475260945 | BIOS Living | LF094 | 2024-08-19 | |
| 20057475260952 | BIOS Living | LF095 | 2024-08-19 | |
| 20057475260976 | BIOS Living | LF097 | 2024-08-19 | |
| 20057475260990 | BIOS Living | LF099 | 2024-08-19 | |
| 10057475267756 | BIOS Living | LF775 | 2024-08-19 | |
| 10057475267763 | BIOS Living | LF776 | 2024-08-19 | |
| 10057475281943 | BIOS Living | LH194 | 2024-08-19 | |
| 10057475283008 | BIOS Living | LH300 | 2024-08-19 | |
| 10057475960015 | BIOS Living | SP001 | 2024-08-19 | |
| 20057475611037 | BIOS Living | FA103 | 2024-07-02 | |
| 20057475611044 | BIOS Living | FA104 | 2024-07-02 | |
| 20057475611051 | BIOS Living | FA105 | 2024-07-02 | |
| 20057475611068 | BIOS Living | FA106 | 2024-07-02 | |
| 20057475611075 | BIOS Living | FA107 | 2024-07-02 | |
| 20057475611204 | BIOS Living | FA120 | 2024-07-02 | |
| 10057475160514 | BIOS Diagnostics | NS160 | 2024-06-17 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 16974500613552 | Elbow Support | GCMEDICA ENTERPRISE LTD.(WUXI) | IOY | 2025-12-12 |
| 16974500613590 | Shoulder Brace | GCMEDICA ENTERPRISE LTD.(WUXI) | IOY | 2025-12-12 |
| 00636257207710 | MEDI | MEDI MANUFACTURING, INC. | IOY | 2025-09-26 |
| 00636257204924 | MEDI | MEDI MANUFACTURING, INC. | IOY | 2025-06-24 |
| 00636257204931 | MEDI | MEDI MANUFACTURING, INC. | IOY | 2025-06-24 |
| 00636257204948 | MEDI | MEDI MANUFACTURING, INC. | IOY | 2025-06-24 |
| 00636257204955 | MEDI | MEDI MANUFACTURING, INC. | IOY | 2025-06-24 |
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| 04823097723500 | TM "Rehabilitimed" RP-6P S Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723517 | TM "Rehabilitimed" RP-6P XS Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723524 | TM "Rehabilitimed" RP-6P S Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723531 | TM "Rehabilitimed" RP-6P M Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723548 | TM "Rehabilitimed" RP-6P L Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
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| 04823097723616 | TM "Rehabilitimed" RP-6K-M1 UNIp-1 Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723623 | TM "Rehabilitimed" RP-6K-M1 UNI Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097723630 | TM "Rehabilitimed" RP-6K-M1 XXL Comfort | REABILITIMED TOV | IOY | 2025-05-17 |
| 04823097719176 | TM "Rehabilitimed" RP-6 XS Comfort | REABILITIMED TOV | IOY | 2025-05-04 |