ADD-A-SPLINT™ - WRIST / LOWER ARM
- Primary DI
- 10609271483023
- Brand
- ADD-A-SPLINT™ - WRIST / LOWER ARM
- Company
- DARCO INTERNATIONAL, INC.
- Model
- AD-101
- Catalog number
- AD-101
- 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 |
|---|
| 10609271483023 | Package | GS1 | 4 | In Commercial Distribution |
| 20609271483020 | Package | GS1 | 12 | In Commercial Distribution |
| 00609271483026 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10609271483023 | 10609271483023 | | |
| 20609271483020 | 20609271483020 | | |
| 00609271483026 | 00609271483026 | 609271483026 | 0609271483026 |
GMDN Terms
| Term | Definition |
|---|
| First aid limb splint, mouldable, reusable | A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). 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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00190446683407 | PROCARE | DJO, LLC | NOC | 2025-07-08 |
| 00190446683414 | PROCARE | DJO, LLC | NOC | 2025-07-08 |
| 00190446662754 | PROCARE | DJO, LLC | NOC | 2025-07-07 |
| 00190446662761 | PROCARE | DJO, LLC | NOC | 2025-07-07 |
| 00190446662778 | PROCARE | DJO, LLC | NOC | 2025-07-07 |
| 14251853902826 | Body Armor® PFA Walker | Darco (Europe) GmbH | NOC | 2025-04-15 |
| 14251853902833 | Body Armor® PFA Walker | Darco (Europe) GmbH | NOC | 2025-04-15 |
| 14251853902840 | Body Armor® PFA Walker | Darco (Europe) GmbH | NOC | 2025-04-15 |
| 08809818038111 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 08809818038128 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 08809818038135 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 08809818038142 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 08809818038159 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 08809818038166 | Guardian Splint | BM KOREA CO., LTD | NOC | 2025-03-20 |
| 06977071937501 | Meicen | Guangdong Meicen Medical Equipment Co., Ltd. | NOC | 2024-06-21 |
| 00810003753700 | KENTEX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-19 |
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| 00810003753922 | KENAFLEXX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-19 |
| 00810003753540 | KENTEX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-18 |
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| 00810003753601 | KENTEX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-18 |
| 00810003753625 | KENTEX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-18 |
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| 00810003753663 | KENTEX | KENTRON HEALTHCARE, INC. | NOC | 2024-02-18 |