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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
Orthopaedic bur, single-use FDA UDI
Device Name
ROUND BALL CUTTER,DIAMOND, LONG, 3mm DIA. FDA UDI
Model / Reference
ZB-262 FDA UDI
Description
ROUND BALL CUTTER,DIAMOND, LONG, 3mm DIA. FDA UDI

Identifiers

Primary DI / UDI-DI
00847399012913 FDA UDI
FDA Product Code
GFF FDA UDI
GMDN Term
Orthopaedic bur, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3 Millimeter FDA UDI
Length — 3 Millimeter FDA UDI

Category: Orthopaedic bur, single-use

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

Similar devices

Also classified as Orthopaedic bur, single-use.

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 90b9dabd-0a63-49a5-955d-97d23a9547c6 34 fields · synced Jun 9, 2026