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Spinal surgery working sleeves
EUDAMEDFDA UDIClass I (EU MDR)
Ref 892209012Model 10000230839
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Spinal surgery working sleeves EUDAMEDWORKING SLEEVE ID 14.5MM OD 15.5MM TL 145mm, Distal end with double window, reusable FDA UDI
- Model / Reference
- 10000230839 EUDAMED892209012 EUDAMEDFDA UDI
- Description
- WORKING SLEEVE ID 14.5MM OD 15.5MM TL 145mm, Distal end with double window, reusable FDA UDI
Identifiers
- Catalog Number
- 892209012 FDA UDI
- Primary DI / UDI-DI
- 04055207068373 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520716102019-0017628FH EUDAMED
- Direct Marketing DI
- 04055207068373 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Endoscope sheath, 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 — 15.5 Millimeter FDA UDILength — 145 Millimeter FDA UDILumen/Inner Diameter — 14.5 Millimeter FDA UDI
Category: Rigid endoscope obturator
Spinal surgery working sleeves 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.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- 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 | 405520716102019-0017628FH | 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 47e53eb5-5fce-422d-9067-cff050aae1e4 61 fields · synced Jul 26, 2026
- FDA UDI 3318f3f3-a802-4751-9ac6-a65503874b7c 37 fields · synced May 25, 2026