Identity
- Trade Name
- MicroAire® FDA UDI
- Generic Name
- Surgical power tool hand-switch FDA UDI
- Device Name
- ELECTRIC MOTOR MODULE WITH HANDSWITCH FDA UDI
- Model / Reference
- 1000ET FDA UDI
- Description
- ELECTRIC MOTOR MODULE WITH HANDSWITCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399000736 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Surgical power tool hand-switch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
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: Surgical power tool hand-switch
MicroAire® by MicroAire Surgical Instruments LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool hand-switch.
- STRYKER — Stryker Corp. · Class II
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- CORE — Stryker Corp. · Class II
- DISPOSABLE HANDSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC. · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Midas Rex MR8 — Medtronic PS Medical · Class II
- CORE, Sumex — Stryker Corp. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
Sources (1)
- FDA UDI 5be7339b-010e-4ae6-b4b9-5428f7dc19e0 33 fields · synced Jun 9, 2026