Identity
- Trade Name
- Rongeur Forceps for Cement Extraction, 278mm O/L FDA UDI
- Generic Name
- Orthopaedic cement extractor, manual FDA UDI
- Model / Reference
- PN0218 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056405501517 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Orthopaedic cement extractor, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement extractor, manual
Rongeur Forceps for Cement Extraction, 278mm O/L by Platts & Nisbett Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement extractor, manual.
- BIRMINGHAM HIP — Smith & Nephew, Inc. · Class III
- BiMobile Dual Mobility System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- RENOVATION — Smith & Nephew, Inc. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- LINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KG · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Platts & Nisbett Limited
Sources (1)
- FDA UDI 2f8c3fef-af9d-4bcd-b50d-b11e3f5ce597 32 fields · synced Jun 8, 2026