Elite Orthopaedics
- Primary DI
- 00816591013400
- Brand
- Elite Orthopaedics
- Company
- Elite Orthopaedics, Inc.
- Model
- K80034-R
- Catalog number
- K80034-R
- Device description
- Adjustable Elbow Brace, Right
- Published
- 2023-08-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| IQQ | Joint, Shoulder, External Limb Component |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| IQQ | Joint, Shoulder, External Limb Component | Physical Medicine | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816591013400 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816591013400 | 00816591013400 | 816591013400 | 0816591013400 |
GMDN Terms#
| Term | Definition |
|---|---|
| Elbow immobilizer | A non-rigid device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 803168228
- Device count
- 1
- Premarket exempt
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816591010690 | Elite Orthopaedics | 30061-R | 30061-R | 2023-08-17 |
| 00816591010706 | Elite Orthopaedics | 30061-L | 30061-L | 2023-08-17 |
| 00816591010713 | Elite Orthopaedics | 30062-R | 30062-R | 2023-08-17 |
| 00816591010720 | Elite Orthopaedics | 30062-L | 30062-L | 2023-08-17 |
| 00816591010737 | Elite Orthopaedics | 30063-R | 30063-R | 2023-08-17 |
| 00816591010744 | Elite Orthopaedics | 30063-L | 30063-L | 2023-08-17 |
| 00816591010751 | Elite Orthopaedics | 30064-R | 30064-R | 2023-08-17 |
| 00816591010768 | Elite Orthopaedics | 30064-L | 30064-L | 2023-08-17 |
| 00816591010775 | Elite Orthopaedics | 30065-R | 30065-R | 2023-08-17 |
| 00816591010782 | Elite Orthopaedics | 30065-L | 30065-L | 2023-08-17 |
| 00816591010799 | Elite Orthopaedics | 31061-R | 31061-R | 2023-08-18 |
| 00816591010805 | Elite Orthopaedics | 31062-R | 31062-R | 2023-08-18 |
| 00816591010812 | Elite Orthopaedics | 31063-R | 31063-R | 2023-08-18 |
| 00816591010829 | Elite Orthopaedics | 31064-R | 31064-R | 2023-08-18 |
| 00816591010836 | Elite Orthopaedics | 31065-R | 31065-R | 2023-08-18 |
| 00816591010843 | Elite Orthopaedics | 31061-L | 31061-L | 2023-08-18 |
| 00816591010850 | Elite Orthopaedics | 31062-L | 31062-L | 2023-08-18 |
| 00816591010867 | Elite Orthopaedics | 31063-L | 31063-L | 2023-08-18 |
| 00816591010874 | Elite Orthopaedics | 31064-L | 31064-L | 2023-08-18 |
| 00816591010881 | Elite Orthopaedics | 31065-L | 31065-L | 2023-08-18 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850071315509 | Trend | Orthofix US LLC | IQQ | 2026-04-25 |
| 00850071315516 | Trend | Orthofix US LLC | IQQ | 2026-04-25 |
| 00850071315486 | Trend | Orthofix US LLC | IQQ | 2026-04-23 |
| 00850071315493 | Trend | Orthofix US LLC | IQQ | 2026-04-23 |
| 00810113683539 | ManaEZ Shoulder Ice CureTech | Manamed, Inc. | IQQ | 2025-10-03 |
| 08936235650005 | Fullerton Manufacturing Limited | FULLERTON MANUFACTURING LIMITED | IQQ | 2025-07-02 |
| 04719883461698 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883463432 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883463449 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883463456 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883463463 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883464286 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883464859 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883464866 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883464873 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 04719883464880 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2025-01-10 |
| 00810179880958 | Copperfit | Ideavillage Products Corp | IQQ | 2024-11-18 |
| 00810179880965 | Copperfit | Ideavillage Products Corp | IQQ | 2024-11-18 |
| 00850012035312 | Unite Medical® | Unite Medical, LLC | IQQ | 2024-06-20 |
| 00749756394734 | DeRoyal | DEROYAL INDUSTRIES, INC. | IQQ | 2024-06-06 |
| 50749756394739 | DeRoyal | DEROYAL INDUSTRIES, INC. | IQQ | 2024-06-06 |
| 04719883460165 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460523 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460554 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460608 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460622 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460660 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460714 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460745 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |
| 04719883460912 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IQQ | 2023-10-31 |