DARCO® Body Armor® Night Splint
- Primary DI
- 20609271899166
- Brand
- DARCO® Body Armor® Night Splint
- Company
- DARCO INTERNATIONAL, INC.
- Model
- BADS-S
- Catalog number
- BADS-S
- Device description
- S Blue
- Published
- 2023-02-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NOC | Splint, extremity, non-inflatable, external, non-sterile |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10609271899169 | Package | GS1 | 4 | In Commercial Distribution |
| 20609271899166 | Package | GS1 | 12 | In Commercial Distribution |
| 00609271899162 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10609271899169 | 10609271899169 | | |
| 20609271899166 | 20609271899166 | | |
| 00609271899162 | 00609271899162 | 609271899162 | 0609271899162 |
GMDN Terms
| Term | Definition |
|---|
| Inflatable extremity splint | A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device. |
Regulatory Flags
- DUNS number
- 184231298
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- 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
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| 08809818038166 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
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