FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399000804
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
1100-006
Device description
BUR GUARD, EXTRA LONG, FOR 1930/5930 INSTRUMENT
Published
2021-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00847399000804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399000804008473990008048473990008040847399000804

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity91 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103056420
Device count
1
Premarket exempt
true
Serial number
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
00847399007186MicroAire® Microaire Surgical Instruments LLCLXZ2022-03-30
00847399000798MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399003690MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399007001MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-29
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507073874694483M™ Comply™3M COMPANYLXZ2021-06-18
507073874694553M™ Comply™3M COMPANYLXZ2021-06-18
507073874694623M™ Comply™3M COMPANYLXZ2021-06-18
10884527010219DevonCardinal Health, Inc.LXZ2018-06-23