FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399007186
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
K-22NS
Device description
SST BUR, LINDEMANN, 4 Flutes x 2.2mm Dia.
Published
2022-03-30
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXZGuard, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXZGuard, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399007186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399007186008473990071868473990071860847399007186

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter2.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103056420
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847399003591MicroAire® 2500-1002022-02-07
00847399003607MicroAire® 2500-2002022-02-07
00847399017406MicroAire®CART-CLAMP2025-08-01
00847399017413MicroAire® 70202025-08-01
00847399017420MicroAire® 7020-PAL2025-08-01
00847399017437MicroAire®5020-ASP2025-08-01
00847399017444MicroAire®7020-ASP2025-08-01
00847399017451MicroAire®7020-INF2025-08-01
00847399017468MicroAire®7020-PEDAL2025-08-01
00847399017475MicroAire® ASP-PUMP-1202025-08-01
00847399017482MicroAire® ASP-UI2025-08-01
00847399017499MicroAire® ASP-CBL2025-08-01
00847399017505MicroAire®ASP-FOOT2025-08-01
00847399017512MicroAire®ASP-FLTR22025-08-01
00847399017536MicroAire®CART2025-08-01
00847399017543MicroAire®CART-RING2025-08-01
00847399017550MicroAire®CART-IV-POLE2025-08-01
00847399018960MicroAire®ASP-TUBING2025-08-01
00847399019004MicroAire®CART-POLE2025-08-01
00847399019011MicroAire®CART-BASKET2025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770418640Bausch + LombBausch & Lomb IncorporatedLXZ2025-08-18
04262488440044TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440037TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440020TissueGUARDTissueGUARD GmbHLXZ2025-04-24
04262488440013TissueGUARDTissueGUARD GmbHLXZ2025-04-24
10843356102694CYGNUSCYGNUS MEDICAL L.L.C.LXZ2024-12-11
00822409101160N/AOrtho Development CorporationLXZ2023-10-06
B7689188290Buxton BioMedicalBuxton Biomedical IncLXZ2023-07-07
00822409104031n/aOrtho Development CorporationLXZ2022-05-01
00847399000798MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399000804MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399003690MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399007001MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-29
107073877920053M™ Attest™3M COMPANYLXZ2021-06-18
107073877920123M™ Attest™3M COMPANYLXZ2021-06-18
107073877920293M™ Attest™3M COMPANYLXZ2021-06-18
307073874694443M™ Comply™3M COMPANYLXZ2021-06-18
307073874694513M™ Comply™3M COMPANYLXZ2021-06-18
307073874694683M™ Comply™3M COMPANYLXZ2021-06-18
507073877920033M™ Attest™3M COMPANYLXZ2021-06-18
507073877920103M™ Attest™3M COMPANYLXZ2021-06-18
507073877920273M™ Attest™3M COMPANYLXZ2021-06-18
507073874694483M™ Comply™3M COMPANYLXZ2021-06-18
507073874694553M™ Comply™3M COMPANYLXZ2021-06-18
507073874694623M™ Comply™3M COMPANYLXZ2021-06-18
10884527010219DevonCardinal Health, Inc.LXZ2018-06-23