Identity
- Trade Name
- ROSCOE MEDICAL FDA UDI
- Generic Name
- Perineal/coccygeal cushion FDA UDI
- Device Name
- INVALID RING, 16 MOLDED FOAM FDA UDI
- Model / Reference
- IR-16 FDA UDI
- Description
- INVALID RING, 16 MOLDED FOAM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00092237604007 FDA UDI
- FDA Product Code
- LRL FDA UDI
- GMDN Term
- Perineal/coccygeal cushion FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perineal/coccygeal cushion
Roscoe Medical by Compass Health Brands Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perineal/coccygeal cushion.
- Ever-Soft Coccyx Foam Cushion, 20"x16"x3" — Dynarex Corp. · Class I
- Ever-Soft Coccyx Foam Cushion, 18"x16"x3" — Dynarex Corp. · Class I
- Ever-Soft Coccyx Gel Foam Cushion, 18"x16"x3" — Dynarex Corp. · Class I
- Ever-Soft Coccyx Gel Foam Cushion, 20"x16"x3" — Dynarex Corp. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- ContourMD — ContourMD Marketing Group, LLC · Class I
- ContourMD — ContourMD Marketing Group, LLC · Class I
- ROSCOE MEDICAL — COMPASS HEALTH BRANDS CORP. · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI e08b1f65-cb32-45e2-b230-8d5e99af60b1 34 fields · synced May 30, 2026