FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399005472
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
8053-148
Device description
SST TAP, 4.5mm Dia,X-LONG, 3.2mm DRILL, 4.5mm SCREW
Published
2022-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399005472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399005472008473990054728473990054720847399005472

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, single-use, sterileA sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length83Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103056420
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00763000674397MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-10-23
08059386749203Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-10-23
04719886913330Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HTW2026-10-15
00889795150141APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795151728APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00190446960324DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960331DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960348DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960409DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960416DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00889024715271Affixus®Zimmer, Inc.HTW2026-10-06
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23