Identity
- Trade Name
- RALLY FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- RALLY HV ALL IN ONE SYSTEM 70 GRAMS FDA UDI
- Model / Reference
- 71271605 FDA UDI
- Description
- RALLY HV ALL IN ONE SYSTEM 70 GRAMS FDA UDI
Identifiers
- Catalog Number
- 71271605 FDA UDI
- Primary DI / UDI-DI
- 00885556646403 FDA UDI
- 510(k) Number
- K143134 FDA UDI
- FDA Product Code
- LOD FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 70 Gram FDA UDI
Category: Orthopaedic cement preparation/delivery kit
Rally by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PicoMix Bowl — G21 SRL · Class I
Cleared under the same submission
K143134 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI c43e04c1-14de-4078-b31a-ec5ab7f96238 38 fields · synced Jun 8, 2026