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U-joint chain dual coupling for carbon offset reamer handle
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- U-joint chain dual coupling for carbon offset reamer handle FDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Model / Reference
- T18198 FDA UDI
Identifiers
- Catalog Number
- T18198 FDA UDI
- Primary DI / UDI-DI
- 07640187917666 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
U-joint chain dual coupling for carbon offset reamer handle by MPS Micro Precision Systems AG — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Surgical power tool adaptor.
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- HAMMR™ — Biomet Orthopedics, Inc. · Class I
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- Enztec Straight Reamer Driver – Locking – Bridgeback – Large AO — ENZTEC LIMITED · 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 |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (1)
- FDA UDI de08b8c1-862b-4b4a-9454-b16688cc31e0 34 fields · synced May 31, 2026