Identity
- Trade Name
- MicroAire® FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- LIGHT POST ADAPTER, STORZ, SMARTRELEASE FDA UDI
- Model / Reference
- 81151 FDA UDI
- Description
- LIGHT POST ADAPTER, STORZ, SMARTRELEASE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399017277 FDA UDI
- 510(k) Number
- K223406 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Category: Light source adaptor
MicroAire® by MicroAire Surgical Instruments LLC — 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
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
- MicroAire Surgical Instruments LLC
Sources (1)
- FDA UDI 94555903-af43-4b37-845f-a92530e2ea6f 34 fields · synced Jun 9, 2026