Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid endoscope telescope FDA UDI
- Device Name
- Telescope, 30°, wideangle, 4 mm FDA UDI
- Model / Reference
- A22005A FDA UDI
- Description
- Telescope, 30°, wideangle, 4 mm FDA UDI
Identifiers
- Catalog Number
- A22005A FDA UDI
- Primary DI / UDI-DI
- 04042761020886 FDA UDI
- 510(k) Number
- K897003 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid endoscope telescope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Cleared under the same submission
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 30cbeac2-35dc-4002-9334-cf8abf9daa22 37 fields · synced Jun 1, 2026