Bio Leg 2™
- Primary DI
- 00850092871008
- Brand
- Bio Leg 2™
- Company
- BIONICM INC.
- Model
- SN008
- Device description
- Robotic prosthetic knee joint, black, large, knee unit only
- Published
- 2026-11-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| ISY | Joint, Knee, External Limb Component |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| ISY | Joint, Knee, External Limb Component | Physical Medicine | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850092871008 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850092871008 | 00850092871008 | 850092871008 | 0850092871008 |
Regulatory Flags#
- DUNS number
- 717916018
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- 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#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850092871015 | Bio Leg 2™ | BIONICM INC. | ISY | 2026-11-01 |
| 00850092871022 | Bio Leg 2™ | BIONICM INC. | ISY | 2026-11-01 |
| 00850092871039 | Bio Leg 2™ | BIONICM INC. | ISY | 2026-11-01 |
| 00860010894866 | ASISTA™ | BIONICM INC. | ISY | 2026-11-01 |
| 00860010894873 | ASISTA™ | BIONICM INC. | ISY | 2026-11-01 |
| 00860010894880 | ASISTA™ | BIONICM INC. | ISY | 2026-11-01 |
| 00860010894897 | ASISTA™ | BIONICM INC. | ISY | 2026-11-01 |
| 00195411012053 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2026-10-01 |
| 00841747186936 | Aura Plus | COLLEGE PARK INDUSTRIES, INC. | ISY | 2026-01-29 |
| 00841747186943 | Aura Plus | COLLEGE PARK INDUSTRIES, INC. | ISY | 2026-01-29 |
| 00195411458905 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2025-05-28 |
| 00194711121014 | Intuy | Willowwood Global LLC | ISY | 2025-03-21 |
| 00194711121021 | Intuy | Willowwood Global LLC | ISY | 2025-03-21 |
| 00713980034377 | BIOSTEP XT | Alps South, LLC | ISY | 2025-01-14 |
| 04719883460356 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2025-01-10 |
| 04719883460370 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2025-01-10 |
| 00195411458820 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 00195411458837 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 00195411458844 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 00195411458851 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 00195411458868 | Icon | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 00841747186707 | Aura | COLLEGE PARK INDUSTRIES, INC. | ISY | 2024-06-19 |
| 04719883460004 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460028 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460035 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460059 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460066 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460073 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460103 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |
| 04719883460110 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | ISY | 2023-10-31 |