Cast boot, canvas
- Primary DI
- 20609271069415
- Brand
- Cast boot, canvas
- Company
- DARCO INTERNATIONAL, INC.
- Model
- CBO4
- Catalog number
- CBO4
- Device description
- Extra-large Navy Open-toe
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| IPG | Shoe, Cast | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10609271069418 | Package | GS1 | 12 | In Commercial Distribution |
| 20609271069415 | Package | GS1 | 36 | In Commercial Distribution |
| 00609271069411 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10609271069418 | 10609271069418 | | |
| 20609271069415 | 20609271069415 | | |
| 00609271069411 | 00609271069411 | 609271069411 | 0609271069411 |
GMDN Terms
| Term | Definition |
|---|
| Cast boot | A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. |
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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