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Cannulated spherical reamer ⌀9 mm PLUS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 112-A22200Ref 112-A22000
Identity
- Trade Name
- Cannulated spherical reamer ⌀9 mm PLUS EUDAMEDCannulated spherical reamer ⌀ 9 mm EUDAMEDTouch CMC 1 - Cannulated Spherical Reamer Ø9 FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Reamers EUDAMED
- Model / Reference
- 112-A22200 EUDAMED112-A22000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181163007 EUDAMED07640181161188 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116016B9 EUDAMED
- PMA Number
- P240020 FDA UDI
- FDA Product Code
- SFA FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
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
Cannulated spherical reamer ⌀9 mm PLUS by Keri Medical SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018116016B9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keri Medical SA
- EUDAMED SRN
- CH-MF-000021960
- Authorised Representative
- Keri Medical France FR-AR-000009590
Sources (3)
- EUDAMED 70488906-c0e3-45a6-a3a9-d33179ca02ee 61 fields · synced Oct 6, 2026
- FDA UDI 0d63ac12-7d5b-4d7d-97bc-2f6645f0da9a 33 fields · synced May 27, 2026
- EUDAMED 38807995-b3d5-4c2c-8fd9-72ebbffe3d6b 61 fields · synced Jul 9, 2026