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Spinal surgery dilators
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89220913Model 10000230838Ref 89220922Ref 89220923
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Spinal surgery dilators EUDAMEDDILATOR ID 9.5MM OD 13.5MM TL 210mm, reusable FDA UDI
- Model / Reference
- 10000230838 EUDAMED89220913 EUDAMEDFDA UDI89220922 EUDAMED89220923 EUDAMED
- Description
- DILATOR ID 9.5MM OD 13.5MM TL 210mm, reusable FDA UDI
Identifiers
- Catalog Number
- 89220913 FDA UDI
- Primary DI / UDI-DI
- 04055207068403 EUDAMEDFDA UDI04055207069738 EUDAMED04055207069745 EUDAMED
- Basic UDI-DI
- 405520711112019-001763092 EUDAMED
- Direct Marketing DI
- 04055207068403 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L0925 ORTHOPAEDIC SURGERY DILATORS, REUSABLE EUDAMEDZ12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER 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
- Outer Diameter — 13.5 Millimeter FDA UDILumen/Inner Diameter — 9.5 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 (4)
- EUDAMED 5a1a229e-3839-4278-a3a4-610a9a84925e 61 fields · synced Jul 15, 2026
- EUDAMED 9307cf9b-4658-4a40-9a25-81f48ab627f1 61 fields · synced May 18, 2026
- EUDAMED dff78b76-b905-423f-80d2-d04fff8520be 61 fields · synced May 19, 2026
- FDA UDI 55b1aff4-2f36-45f0-88de-e1e85a85eb2e 37 fields · synced May 30, 2026