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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 handpiece FDA UDI
Device Name
SmartRelease Handpiece FDA UDI
Model / Reference
83014 FDA UDI
Description
SmartRelease Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
00847399015907 FDA UDI
510(k) Number
K211297 FDA UDI
FDA Product Code
EMF FDA UDI
GMDN Term
Endoscopic soft-tissue release system handpiece 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic soft-tissue release system handpiece

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 handpiece.

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 c887bb2e-aa23-4db9-b999-0ebbbf89f59e 34 fields · synced Jun 9, 2026