FDA.reportPublic FDA data

Tandry Orthopedic Manual Surgical Instrument

Primary DI
04719879398021
Brand
Tandry Orthopedic Manual Surgical Instrument
Company
MICROWARE PRECISION CO., LTD.
Model
303008A-500
Device description
DRILL BIT Ø2.8, FOR LCP SMALL FRAGMENT
Published
2025-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04719879398021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879398021047198793980214719879398021

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886424636275harrisondu@microware.com.tw

Regulatory Flags#

DUNS number
658650833
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873099689BIO-RAY A-1 Anchor Screw SystemA-1H-2120082026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemA-1H-2120102026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemA-1H-2120122026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemA-1H-2120142026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemA-1HS-2220082026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemA-1HS-2220102026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemA-1HS-2220122026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemA-1HS-2220142026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemA-1H-4120082026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemA-1H-4120102026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemA-1H-4120122026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemA-1H-4120142026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemA-1PL-4120082026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemA-1PL-4120102026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemA-1PL-4120122026-05-15
04719873100279BIO-RAY A-1 Anchor Screw SystemA-1PL-4120142026-05-15
04719873100286BIO-RAY A-1 Anchor Screw SystemA-1PL-4120172026-05-15
04719873100354BIO-RAY A-1 Anchor Screw SystemA-1DH-4120082026-05-15
04719873100361BIO-RAY A-1 Anchor Screw SystemA-1DH-4120102026-05-15
04719873100378BIO-RAY A-1 Anchor Screw SystemA-1DH-4120122026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017560A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017577A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017584A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00810030811657InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
00810030811671InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05