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Arthroscopic sheaths
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89220.1407Model 10000201091
Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Arthroscopic sheaths EUDAMEDEXTENSION SLEEVE ID 6.1MM OD 7.1MM TL 155mm, distal end straight, reusable FDA UDI
- Model / Reference
- 10000201091 EUDAMED89220.1407 EUDAMED892201407 FDA UDI
- Description
- EXTENSION SLEEVE ID 6.1MM OD 7.1MM TL 155mm, distal end straight, reusable FDA UDI
Identifiers
- Catalog Number
- 89220.1407 FDA UDI
- Primary DI / UDI-DI
- 04055207046838 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520720052019-0017663DG EUDAMED
- Direct Marketing DI
- 04055207046838 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
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
- Length — 154.6 Millimeter FDA UDIOuter Diameter — 7.1 Millimeter FDA UDILumen/Inner Diameter — 6.1 Millimeter FDA UDI
Category: Rigid endoscope obturator
Arthroscopic sheaths 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 | 405520720052019-0017663DG | 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 deffca81-ccf4-4357-935b-fa1ad5bac702 61 fields · synced Jun 19, 2026
- FDA UDI e5b243fd-897d-4bd5-97ea-6a348d9a4216 36 fields · synced May 30, 2026