CoreTech
- Primary DI
- 10810041980295
- Brand
- CoreTech
- Company
- VIVE HEALTH LLC
- Model
- SUP2025BLK
- Device description
- 631 LSO Back Brace
- Published
- 2023-06-15
- 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
Product Codes
| Code | Name |
|---|
| IQE | Orthosis, Lumbar |
| ISR | Band Or Belt, Pelvic Support |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 1 |
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10810041980295 | Package | GS1 | 40 | In Commercial Distribution |
| 00810041980298 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10810041980295 | 10810041980295 | | |
| 00810041980298 | 00810041980298 | 810041980298 | 0810041980298 |
GMDN Terms
| Term | Definition |
|---|
| Lumbar spine orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device. |
Regulatory Flags
- DUNS number
- 047025993
- Device count
- 1
- DM exempt
- true
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00810178882533 | CoreTech | VIVE HEALTH LLC | IQE | 2026-02-09 |
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| 00860014460821 | Boston Overlap Brace (BOB) | Boston Brace International, Inc. | IQE | 2025-08-05 |
| 04719879641868 | ComfyHealth | Comfy Health Group Co., Ltd. | ISR | 2025-07-10 |
| 04719879641875 | ComfyHealth | Comfy Health Group Co., Ltd. | ISR | 2025-07-10 |
| 04719879644562 | ComfyHealth | Comfy Health Group Co., Ltd. | ISR | 2025-07-10 |
| 00819567011233 | Comfytopia | Comfytopia, Inc. | ISR | 2025-07-09 |
| 00819567016818 | Comfytopia | Comfytopia, Inc. | ISR | 2025-07-09 |
| 00636257203651 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
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| 00636257203743 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
| 00636257203750 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
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| 00636257204801 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
| 00636257204818 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
| 00636257204825 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
| 00636257204832 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |
| 00636257204849 | MEDI | MEDI MANUFACTURING, INC. | IQE | 2025-06-24 |