MicroAire®

FDA UDI

Class I (US FDA UDI)

by MicroAire Surgical Instruments LLC

Identity

Trade Name: MicroAire® FDA UDI
Generic Name: Surgical instrument guard, reusable FDA UDI
Device Name: BUR GUARD, LONG, FOR 1930/5930 INSTRUMENT FDA UDI
Model / Reference: 1100-005 FDA UDI
Description: BUR GUARD, LONG, FOR 1930/5930 INSTRUMENT FDA UDI

Identifiers

Primary DI / UDI-DI: 00847399000798 FDA UDI
FDA Product Code: LXZ FDA UDI
GMDN Term: Surgical instrument guard, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical instrument guard, reusable

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

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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 95a4b9df-8d9c-4d3f-b1ce-df9a56635f36 34 fields · synced Jun 9, 2026