Identity
- Trade Name
- MicroAire® FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- AUTOCLAVABLE ENDOSCOPE, SMARTRELEASE FDA UDI
- Model / Reference
- 81025 FDA UDI
- Description
- AUTOCLAVABLE ENDOSCOPE, SMARTRELEASE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399017253 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, reusable 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical arthroscope, reusable
MicroAire® by MicroAire Surgical Instruments LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical arthroscope, reusable.
- Arthrex® — Arthrex, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Precision Ideal Eyes — Stryker Corp. · Class II
Cleared under the same submission
K080560 also covers:
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MITEK — Medos International Sàrl
- MicroAire® — MicroAire Surgical Instruments LLC
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
- IRIS Arthroscope — SOLENDOS Inc.
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 443d90cd-2b5e-4925-ad61-4eadefee5614 34 fields · synced Jun 9, 2026