Identity
- Trade Name
- Rapr-Round FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system pad, reusable FDA UDI
- Model / Reference
- 8001-061-560 FDA UDI
Identifiers
- Catalog Number
- 8001-061-560 FDA UDI
- Primary DI / UDI-DI
- 07613327175134 FDA UDI
- 510(k) Number
- K100585 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External circulating-fluid core temperature regulation system pad, reusable
Rapr-Round by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External circulating-fluid core temperature regulation system pad, reusable.
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 66ed6c1c-d621-4241-a005-6d9298a48848 35 fields · synced Jun 1, 2026