Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- LG-adapter, light guide WA032xxA to ACMI telescope FDA UDI
- Model / Reference
- WA03022A FDA UDI
- Description
- LG-adapter, light guide WA032xxA to ACMI telescope FDA UDI
Identifiers
- Catalog Number
- WA03022A FDA UDI
- Primary DI / UDI-DI
- 04042761062282 FDA UDI
- 510(k) Number
- K912362 FDA UDI
- FDA Product Code
- EWY FDA UDI
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4720 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Light source adaptor
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Light source adaptor.
- Aspen® Rigid Light Handle Adapter — Aspen Surgical Products, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc. · Class II
- Aspen® Flexible Light Handle Cover — Aspen Surgical Products, Inc. · Class II
- Aspen® Flexible Light Handle Adapter — Aspen Surgical Products, Inc. · Class II
- Innomed, Inc. — Innomed, Inc. · Class II
- Aspen® Rigid Light Handle Adapter — Aspen Surgical Products, Inc. · Class II
- SPOTLIGHT — Depuy Spine, Inc. · Class I
Cleared under the same submission
K912362 also covers:
- Olmypus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI a6dadc62-02d3-47c5-a7c5-6583b29af985 36 fields · synced May 29, 2026