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Mountaineer Oct Spinal System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 288308210Model Measuring Instruments -Taps
Identity
- Trade Name
- MOUNTAINEER OCT SPINAL SYSTEM EUDAMEDMOUNTAINEER FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Reusable Bone Taps EUDAMEDMOUNTAINEER OCT SPINAL SYSTEM TAP 3.0mm 10-30mm Plus or Minus 1.00 Percent FDA UDI
- Model / Reference
- Measuring Instruments -Taps EUDAMED288308210 EUDAMEDFDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM TAP 3.0mm 10-30mm Plus or Minus 1.00 Percent FDA UDI
Identifiers
- Catalog Number
- 288308210 FDA UDI
- Primary DI / UDI-DI
- 10705034221595 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001876F EUDAMED
- Direct Marketing DI
- 10705034221595 EUDAMED
- FDA Product Code
- HWX FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
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: Bone cutting forceps, reusable
Mountaineer Oct Spinal System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0705034a001876F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED a84bf495-dc10-445b-9e10-b4a0f36ae000 61 fields · synced Jul 15, 2026
- FDA UDI ca2c7b25-9baf-4e8a-bcc8-0306e9f49dcb 35 fields · synced May 30, 2026