Identity
- Trade Name
- PREP-IM FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- PREP IM ENCHANCED TOTAL HIP BONE PREPARATION KIT FDA UDI
- Model / Reference
- 121010 FDA UDI
- Description
- PREP IM ENCHANCED TOTAL HIP BONE PREPARATION KIT FDA UDI
Identifiers
- Catalog Number
- 121010 FDA UDI
- Primary DI / UDI-DI
- 03596010457127 FDA UDI
- 510(k) Number
- K791125 FDA UDI
- FDA Product Code
- LZN FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement preparation/delivery kit
Prep-Im by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement preparation/delivery kit.
- PicoMix Syringe — G21 SRL · Class I
- MEDINAUT-Ix — IMEDICOM CO., LTD. · Class I
- Arthrex Bone Cement Mixing Syringe — G21 SRL · Class I
- Revolution — Stryker Corp. · Class I
- LITe BIO Delivery System — Stryker Corp. · Class II
- StabiliT® — Merit Medical Systems, Inc. · Class II
- CEMEX SYSTEM FAST 70G — Tecres · Class II
- PicoMix Bowl — G21 SRL · Class I
Cleared under the same submission
K791125 also covers:
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- Spectron — Smith & Nephew, Inc.
- Spectron — Smith & Nephew, Inc.
- Spectron — Smith & Nephew, Inc.
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 e6e82f8d-1495-4997-aba1-2caa43e979a1 36 fields · synced Jun 8, 2026