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Spinal surgery handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 892006038Model 10000201079
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Spinal surgery handles EUDAMEDHANDLE ATTACHM.WORK.CHANNEL OD 14MM reusable FDA UDI
- Model / Reference
- 10000201079 EUDAMED892006038 EUDAMEDFDA UDI
- Description
- HANDLE ATTACHM.WORK.CHANNEL OD 14MM reusable FDA UDI
Identifiers
- Catalog Number
- 892006038 FDA UDI
- Primary DI / UDI-DI
- 04055207034996 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017647PT EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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
No
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 — 14 Millimeter FDA UDI
Category: Rigid endoscope obturator
Spinal surgery handles by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
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- Trabecular Metal® — Zimmer, Inc. · Class I
- Obturator — SOPRO-COMEG GmbH · Class II
- Obturator — SOPRO-COMEG GmbH · Class II
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 | 405520727052019-0017647PT | 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 244f9783-0ce6-400d-b4a5-3f4d5cc05437 61 fields · synced Jun 18, 2026
- FDA UDI 0c4b7ecf-137d-4012-af33-c732de4192de 37 fields · synced May 30, 2026