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MicroAire®

FDA UDI

Class I (US FDA UDI)

by MicroAire Surgical Instruments LLC

Identity

Trade Name
MicroAire® FDA UDI
Generic Name
Endoscopic soft-tissue release system blade FDA UDI
Device Name
Onyx Blade Assembly, SmartRelease FDA UDI
Model / Reference
83030-1 FDA UDI
Description
Onyx Blade Assembly, SmartRelease FDA UDI

Identifiers

Catalog Number
83030-6 FDA UDI
Primary DI / UDI-DI
00847399017246 FDA UDI
510(k) Number
K211297 FDA UDI
FDA Product Code
EMF FDA UDI
GMDN Term
Endoscopic soft-tissue release system blade FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic soft-tissue release system blade

MicroAire® by MicroAire Surgical Instruments LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic soft-tissue release system blade.

Cleared under the same submission

K211297 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroAire Surgical Instruments LLC

Sources (1)

  • FDA UDI f38ef4d9-c6ec-4e8a-a0f1-d55188a68f44 35 fields · synced Jun 9, 2026