Identity
- Trade Name
- Rapr Round FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system pad, reusable FDA UDI
- Model / Reference
- 8001-061-650 FDA UDI
Identifiers
- Catalog Number
- 8001-061-650 FDA UDI
- Primary DI / UDI-DI
- 07613327261394 FDA UDI
- 510(k) Number
- K152266 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
Similar devices
Also classified as External circulating-fluid core temperature regulation system pad, reusable.
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- Plastipad® Pediatric Size — Gentherm Medical, LLC · Class II
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- Arctic Sun® Temperature Management System, ArcticGel™ Pads — Medivance, Inc. · Class II
- Plastipad® Narrow Adult/OR Table Size — Gentherm Medical, LLC · Class II
Cleared under the same submission
K152266 also covers:
- Altrix — Stryker Corp.
- Altrix — Stryker Corp.
- Altrix — Stryker Corp.
- Altrix Temperature Management Hose — Stryker Corp.
- Altrix Temperature Management Hose — Stryker Corp.
- Insulated Clik Tite — Stryker Corp.
- Insulated Clik-Tite — Stryker Corp.
- Insulated Colder Connector — Stryker Corp.
- Insulated Colder Connector — Stryker Corp.
- Rapr Round — Stryker Corp.
- Rapr Round — Stryker Corp.
- Rapr Round — Stryker Corp.
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 9a123ac9-1c5b-477f-ae4f-349ab2a714f1 35 fields · synced May 30, 2026