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Offset reamer handle - Large AO - Tri coupling (NL)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Offset reamer handle - Large AO - Tri coupling (NL) FDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Device Name
- Offset Reamer Handle for hip arthroplasty, non-locking connection FDA UDI
- Model / Reference
- 50244517 FDA UDI
- Description
- Offset Reamer Handle for hip arthroplasty, non-locking connection FDA UDI
Identifiers
- Catalog Number
- 50244517 FDA UDI
- Primary DI / UDI-DI
- 07630055302533 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical power tool adaptor 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool adaptor
Offset reamer handle - Large AO - Tri coupling (NL) by Incipio Devices — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool adaptor.
- HAMMR™ — Biomet Orthopedics, Inc. · Class I
- Mod Inserter Connector — Zimmer, Inc. · Class I
- Carbon offset reamer handle Harris with parking — MPS Micro Precision Systems AG · Class I
- Enztec Straight Reamer Driver – Locking – Bridgeback – Hudson — ENZTEC LIMITED · Class I
- HAMMR™ — Biomet Orthopedics, Inc. · Class I
- Enztec ORD - Corin - Open - Zimmer — ENZTEC LIMITED · Class I
- Enztec Straight Reamer Driver – Locking – Bridgeback – Large AO — ENZTEC LIMITED · Class I
- HAMMR™ — Biomet Orthopedics, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Incipio Devices
Sources (2)
- FDA UDI ad0fa2e7-4ee0-488e-96be-7018fc1ba1a2 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026