FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399004864
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
7505-050
Device description
PIN DRIVER COUPLER
Published
2021-12-30
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

Product Codes#

Code, Name table
CodeName
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399004864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399004864008473990048648473990048640847399004864

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
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536800244Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
00840536800251Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
07901125600706Minidriver SolarisGM DOS REIS INDUSTRIA E COMERCIO LTDAKIJ2026-02-20
07649988202209FiberLocker PowerUnit - Transfer ShieldZuriMED Technologies AGKIJ2026-02-02
07649988202278FiberLocker PowerUnit - HandpieceZuriMED Technologies AGKIJ2026-02-02
07649988202285FiberLocker PowerUnit - Motor PackZuriMED Technologies AGKIJ2026-02-02
07649988202292FiberLocker PowerUnit - Charging StationZuriMED Technologies AGKIJ2026-02-02
08800038060319EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060326EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060333EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060340EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
00850056900102Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
08800068959348LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959355LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959645LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800017270258BENCOX Surgical InstrumentsCorentec Co., LtdKIJ2025-09-24
08809260475052TD-AUTOSaeshin Precision Co., Ltd.KIJ2025-07-22
008401944934513P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937723P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937893P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944938883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863123P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863293P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321866883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19