DeRoyal
- Primary DI
- 00749756004763
- Brand
- DeRoyal
- Company
- DEROYAL INDUSTRIES, INC.
- Model
- 2021-14
- Catalog number
- 2021-14
- Device description
- POST-OP SHOE
- Published
- 2021-07-21
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| IPG | Shoe, Cast | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00749756004763 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00749756004763 | 00749756004763 | 749756004763 | 0749756004763 |
GMDN Terms
| Term | Definition |
|---|
| Cast shoe, single-use | A footwear designed to be worn over a foot that is encased in a cast in order to protect the cast material and add stability for the patient while ambulating. Its foot bed provides comfort when ambulating and it may or may not protect the toes. It is available in a variety of designs and sizes and can be typically used both indoors and outdoors; some types may be used without a cast, e.g., in the case of a toe fracture. This is a disposable device that is intended for a single-patient use. |
Regulatory Flags
- DUNS number
- 096372255
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| G0648317270026770 | GAITKEEPER® Cast Shoe | Walgreen Health Solutions, LLC | IPG | 2024-08-27 |
| G0648317270026840 | GAITKEEPER® Cast Shoe | Walgreen Health Solutions, LLC | IPG | 2024-08-27 |
| G0648317270026910 | GAITKEEPER® Cast Shoe | Walgreen Health Solutions, LLC | IPG | 2024-08-27 |
| 10810113576395 | CoreTech | VIVE HEALTH LLC | IPG | 2024-06-10 |
| 10810113576401 | CoreTech | VIVE HEALTH LLC | IPG | 2024-06-10 |
| 10810113576418 | CoreTech | VIVE HEALTH LLC | IPG | 2024-06-10 |
| 10810113576425 | CoreTech | VIVE HEALTH LLC | IPG | 2024-06-10 |
| 10810113575978 | VIVE | VIVE HEALTH LLC | IPG | 2024-06-05 |
| 00810060883488 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 00810060883587 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 00810060883594 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 00810060888025 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 00810060888032 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 00810060888049 | Rhino | MD ORTHOPAEDICS, INC. | IPG | 2023-12-20 |
| 10810041980059 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
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| 10810041980066 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980073 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980080 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980097 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980103 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980110 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980127 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10810041980134 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10818323029649 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10818323029656 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10818323029663 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10818323029670 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 10818323029687 | Vive | VIVE HEALTH LLC | IPG | 2023-10-18 |
| 00816591011116 | Elite Orthopaedics | Elite Orthopaedics, Inc. | IPG | 2023-08-15 |
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