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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
Bone/joint surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
HUDSON(R) REAMER COUPLER FDA UDI
Model / Reference
7100-008 FDA UDI
Description
HUDSON(R) REAMER COUPLER FDA UDI

Identifiers

Primary DI / UDI-DI
00847399004611 FDA UDI
FDA Product Code
KIJ FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, pneumatic 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, pneumatic

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

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, pneumatic.

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 9f4dc359-9bff-49bb-8b29-633965f34e0b 33 fields · synced Jun 9, 2026