FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399003874
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
5641-045
Device description
WIRE DRIVER MODULE, SMARTDRIVER DUO-e ONLY
Published
2021-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399003874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399003874008473990038748473990038740847399003874

GMDN Terms#

Term, Definition table
TermDefinition
Wire-driving 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 wire driving/insertion function when an appropriate orthopaedic wire is inserted, e.g., Kirschner wires or K-Wires (thin pins that are pointed for self-drilling). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device.

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
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2026-03-09
10845854028636POWERPROConmed CorporationHSZ2023-09-01
10845854036198POWERPROConmed CorporationHSZ2023-09-01
10845854036204POWERPROConmed CorporationHSZ2023-09-01
30845854083950CONMEDConmed CorporationHSZ2022-06-06
10845854028384POWERPROConmed CorporationHSZ2021-04-19
10886982186041NASynthes GmbHHSZ2019-12-27
10886982186126NASynthes GmbHHSZ2019-12-27
10886982186317NASynthes GmbHHSZ2019-12-27
10886982186355NASynthes GmbHHSZ2019-12-27
10886982186430NASynthes GmbHHSZ2019-12-27
10886982186454NASynthes GmbHHSZ2019-12-27
10886982186478NASynthes GmbHHSZ2019-12-27
10886982186492NASynthes GmbHHSZ2019-12-27
10886982186515NASynthes GmbHHSZ2019-12-27
10886982186553NASynthes GmbHHSZ2019-12-27
10886982186645NASynthes GmbHHSZ2019-12-27
10886982186706NASynthes GmbHHSZ2019-12-27
10886982186775NASynthes GmbHHSZ2019-12-27
10886982186850NASynthes GmbHHSZ2019-12-27
10886982186874NASynthes GmbHHSZ2019-12-27
10886982185914NASynthes GmbHHSZ2019-12-26
10886982185976NASynthes GmbHHSZ2019-12-26
10886982186034NASynthes GmbHHSZ2019-12-26
10886982186119NASynthes GmbHHSZ2019-12-26
10886982186201NASynthes GmbHHSZ2019-12-26
10886982186218NASynthes GmbHHSZ2019-12-26
10886982186249NASynthes GmbHHSZ2019-12-26
10886982186270NASynthes GmbHHSZ2019-12-26
10886982186294NASynthes GmbHHSZ2019-12-26