Identity
- Trade Name
- Acetabular reamer Ø60 with round tooth FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- Acetabular reamer for hip arthroplasty FDA UDI
- Model / Reference
- T18034 FDA UDI
- Description
- Acetabular reamer for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- T18034 FDA UDI
- Primary DI / UDI-DI
- 07640187913439 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Acetabular orthopaedic reamer 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: Acetabular orthopaedic reamer
Acetabular reamer Ø60 with round tooth by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
- Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (2)
- FDA UDI f60bcd68-1e8f-4177-9567-7f6bd320576a 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026