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Spinal surgery dilators
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89220912Model 10000230838
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Spinal surgery dilators EUDAMEDDILATOR ID 9.5MM OD 14.4MM TL 210mm, reusable FDA UDI
- Model / Reference
- 10000230838 EUDAMED89220912 EUDAMEDFDA UDI
- Description
- DILATOR ID 9.5MM OD 14.4MM TL 210mm, reusable FDA UDI
Identifiers
- Catalog Number
- 89220912 FDA UDI
- Primary DI / UDI-DI
- 04055207068397 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711112019-001763092 EUDAMED
- Direct Marketing DI
- 04055207068397 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L0925 ORTHOPAEDIC SURGERY DILATORS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic-access dilator, reusable 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
- Lumen/Inner Diameter — 9.5 Millimeter FDA UDIOuter Diameter — 14.4 Millimeter FDA UDILength — 210 Millimeter FDA UDI
Spinal surgery dilators by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 405520711112019-001763092 | 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 8717ca11-7e6d-45c1-8a25-e1979d1dec05 61 fields · synced Jun 17, 2026
- FDA UDI 8d721f4e-672f-4a66-a006-2ba4f620a8c9 37 fields · synced May 25, 2026