CoreTech
- Primary DI
- 00810113570617
- Brand
- CoreTech
- Company
- VIVE HEALTH LLC
- Model
- SUP3015BLK
- Device description
- Humeral Fracture Splint
- Published
- 2023-06-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
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 |
|---|---|---|---|---|
| 10810113570614 | Package | GS1 | 12 | In Commercial Distribution |
| 00810113570617 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10810113570614 | 10810113570614 | ||
| 00810113570617 | 00810113570617 | 810113570617 | 0810113570617 |
GMDN Terms#
| Term | Definition |
|---|---|
| Shoulder immobilizer/orthosis, reusable | A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device. |
Regulatory Flags#
- DUNS number
- 047025993
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810226440104 | Vive | LVA3167BLK | 2026-06-04 | |
| 00810226440111 | Vive | LVA3167BLKPAK2 | 2026-06-04 | |
| 00810178889969 | Vive | LVA3166WHT | 2026-06-03 | |
| 00810178889976 | Vive | LVA3164BBB | 2026-06-03 | |
| 00810178889983 | Vive | LVA3164BBP | 2026-06-03 | |
| 00810178889990 | Vive | LVA3164BGN | 2026-06-03 | |
| 00810226440005 | Vive | LVA3165BB | 2026-06-03 | |
| 00810226440012 | Vive | LVA3165BP | 2026-06-03 | |
| 00810226440029 | Vive | LVA3165GN | 2026-06-03 | |
| 00810226440036 | Vive | SUP3008BLU | 2026-06-03 | |
| 00810226440043 | Vive | SUP3008PNK | 2026-06-03 | |
| 00810178889624 | Vive Breathe | LVA3161 | 2026-06-01 | |
| 00810178889921 | ViveCare | RHB3079S100CT | 2026-05-29 | |
| 00810178889938 | ViveCare | RHB3079M100CT | 2026-05-29 | |
| 00810178889945 | ViveCare | RHB3079L50CT | 2026-05-29 | |
| 00810178889723 | Vive | SUP3158BLKXS | 2026-05-27 | |
| 00810178889730 | Vive | SUP3158BLKS | 2026-05-27 | |
| 00810178889747 | Vive | SUP3158BLKM | 2026-05-27 | |
| 00810178889754 | Vive | SUP3158BLKL | 2026-05-27 | |
| 00810178889761 | Vive | SUP3158BLKXL | 2026-05-27 |
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 |