Ever-Soft Coccyx Foam Cushion
- Primary DI
- 00616784065649
- Brand
- Ever-Soft Coccyx Foam Cushion
- Company
- DYNAREX CORPORATION
- Model
- 10656
- Device description
- Coccyx Foam Cushion 20"x16"x3"
- Published
- 2021-04-22
- 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
- false
Product Codes
| Code | Name |
|---|
| IMP | Cushion, Wheelchair |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784065649 | Package | GS1 | 4 | In Commercial Distribution |
| 00840117307582 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00616784065649 | 00616784065649 | 616784065649 | 0616784065649 |
| 00840117307582 | 00840117307582 | 840117307582 | 0840117307582 |
GMDN Terms
| Term | Definition |
|---|
| Perineal/coccygeal cushion | A soft pillow or pad that is round or oval with a hole in its centre, intended to alleviate pressure on the caudal extremity of the vertebral column (coccyx) and/or perineal area. It is used when sitting to relieve pain from hemorrhoids or during recovery from surgery, pregnancy, or injury. The device is typically made of foam or an air inflatable vinyl or rubber. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 1
- DM exempt
- false
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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