PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 EUDAMEDPENTAX Medical FDA UDI
- Generic Name
- Endoscope patient protection cap, single-use FDA UDI
- Device Name
- Single Use, Sterile Distal End Cap with Elevator EUDAMEDSingle Use, Sterile Distal End Cap with Elevator OE-A63 FDA UDI
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001A042S EUDAMEDOE-A63 FDA UDI
- Description
- Single Use, Sterile Distal End Cap with Elevator OE-A63 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14961333232991 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333010512Y5 EUDAMED
- Unit of Use DI
- 04961333232994 EUDAMED
- FDA Product Code
- FDT FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope patient protection cap, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
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
Yes
Manufacturing Date
Yes
Category: Gastro-urological guidewire, single-use
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 by Hoya Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 4961333010512Y5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 08cd27bb-41de-4b63-aa97-13f74c815a7c 61 fields · synced Jun 8, 2026
- FDA UDI 83e84108-0c6d-42c3-96ae-449950b50e62 33 fields · synced May 30, 2026