FDA UDI
In Commercial Distribution
🇺🇸 United States
ROSCOE MEDICAL
DI: 00092237604014
·
Model: IR-18
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROSCOE MEDICAL
- Primary DI
- 00092237604014
- Version / Model
- IR-18
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-07
- Public Version
- 2
- Public Version Date
- 2023-08-24
- Public Version Status
- Update
- Public Device Record Key
- 1117cadb-0148-43ed-b776-13b8b2df8a62
Device Description
INVALID RING, 18 MOLDED FOAM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRL | Cushion, Hemorrhoid | Unknown | U |
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 |
|---|---|---|---|---|---|---|
| Primary | 00092237604014 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]