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Spinal surgery instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref 892602755Model 10000201518
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Spinal surgery instruments EUDAMEDSICKLE-SHAPED CHISEL Ø 4MM WL 310MM reusable FDA UDI
- Model / Reference
- 10000201518 EUDAMED892602755 EUDAMEDFDA UDI
- Description
- SICKLE-SHAPED CHISEL Ø 4MM WL 310MM reusable FDA UDI
Identifiers
- Catalog Number
- 892602755 FDA UDI
- Primary DI / UDI-DI
- 04055207068298 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520724062021-0037381G3 EUDAMED
- Direct Marketing DI
- 04055207068298 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic chisel FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany 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
No
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
Dimensions & Sizes
- Size
- Length — 310 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Rigid endoscope obturator
Spinal surgery instruments by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid endoscope obturator.
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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 | 405520724062021-0037381G3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 27ef444b-eaf5-4eed-a359-227d7ad36151 61 fields · synced Jul 24, 2026
- FDA UDI 075c767e-a3fd-4cd7-bf27-1e0a73e58661 37 fields · synced May 30, 2026