FDA UDI
In Commercial Distribution
🇺🇸 United States
Ever-Soft Coccyx Foam Cushion
DI: 00840117307582
·
Model: 10656
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ever-Soft Coccyx Foam Cushion
- Primary DI
- 00840117307582
- Version / Model
- 10656
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- 65646351-0f59-4ea6-92db-12ae2ce50d58
Device Description
Coccyx Foam Cushion 20"x16"x3"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34981 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784065649 | GS1 | Shipper | 4 | In Commercial Distribution | |
| Primary | 00840117307582 | GS1 |