PENTAX Medical R/L Assistant Knob OE-B17
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- PENTAX Medical R/L Assistant Knob OE-B17 EUDAMEDPENTAX Medical FDA UDI
- Generic Name
- Device control handling knob FDA UDI
- Device Name
- PENTAX Medical R/L Assistant Knob EUDAMEDPENTAX Medical R/L Assistant Knob OE-B17 FDA UDI
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001A097 EUDAMEDOE-B17 FDA UDI
- Description
- PENTAX Medical R/L Assistant Knob OE-B17 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333254620 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333010520Y4 EUDAMED
- 510(k) Number
- K241213 FDA UDI
- FDA Product Code
- FDF FDA UDIFDS FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Device control handling knob FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Gastro-urological guidewire, single-use
PENTAX Medical R/L Assistant Knob OE-B17 by HOYA Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4961333010520Y4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED c11e24c3-2f85-41f7-b746-be9357b55f2b 61 fields · synced Jun 19, 2026
- FDA UDI faf58b8b-3acf-484e-a679-c3d5e4efa776 34 fields · synced May 30, 2026