Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid optical ureteroscope FDA UDI
- Device Name
- Ureteroscope, 6,4/7,8 Fr. x 430 mm, 7°, straight ocular angle, 4,2 Fr. channel, with WA00395A FDA UDI
- Model / Reference
- WA29048A FDA UDI
- Description
- Ureteroscope, 6,4/7,8 Fr. x 430 mm, 7°, straight ocular angle, 4,2 Fr. channel, with WA00395A FDA UDI
Identifiers
- Catalog Number
- WA29048A FDA UDI
- Primary DI / UDI-DI
- 04042761062510 FDA UDI
- 510(k) Number
- K951855 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Rigid optical ureteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI bfe4f1ef-02ff-4b3a-af6e-2dbdb4fe2b20 37 fields · synced Jun 8, 2026