Identity
- Trade Name
- UroSeal FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope or cystoscope. FDA UDI
- Model / Reference
- 00913410 FDA UDI
- Description
- The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope or cystoscope. FDA UDI
Identifiers
- Catalog Number
- 00913410 FDA UDI
- Primary DI / UDI-DI
- 00724995211530 FDA UDI
- FDA Product Code
- EYK FDA UDI
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope working-channel valve, single-use
UroSeal by US Endoscopy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI a0938f2d-8f78-4fb8-98bb-907144e03a7a 35 fields · synced May 31, 2026