FDA.report

MicroAire®

Primary DI
00847399004147
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
5950
Device description
HALL STYLE SAGITTAL SAW, KEYLESS MODULE
Published
2022-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847399004147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399004147008473990041478473990041470847399004147

GMDN Terms

TermDefinition
Sawing power tool attachment, sagittalA 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 sagittal sawing function when a sagittal saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward and cuts when the blade is powered in a rapid oscillating (side to side) movement. It is typically made of high-grade stainless steel and synthetic materials and is typically of the macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
103056420
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00847399018984MicroAire®PAL-CASE2025-07-24
00847399018373MicroAire®PAL-7502023-10-02

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00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
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09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
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09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
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09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
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09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23