FDA.reportPublic FDA data

Percutaneous Foot Burrs, Arthodesis Burrs

Primary DI
07899258638881
Brand
Percutaneous Foot Burrs, Arthodesis Burrs
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Burrs Wedge
Catalog number
317-03
Device description
MIS MICRO BURRS WEDGE Ø3,1x15.0mm
Published
2024-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTTBurr, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258638881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258638881078992586388817899258638881

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Regulatory Flags#

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258616506Orthopedic InstrumentsSYNDESMOSIS CLAMP314-1002026-07-07
07899258625348Orthopedic InstrumentsGUIDE WIRE Ø1.0x190.0mm WITHOUT THREAD106-812026-07-07
07899258625355Orthopedic Instruments1,0x190mm THREADED GUIDE WIRE106-822026-07-07
07899258633350Orthopedic InstrumentsGUIDE DRILL DOUBLE 2,7mm106-852026-07-07
07899258633367Orthopedic Instruments4.0mm CANCELLOUS TAP106-862026-07-07
07899258633374Orthopedic InstrumentsSMALL DEPTH GAUGE106-872026-07-07
07899258633381Orthopedic InstrumentsØ1.0x250.0mm WIRE106-882026-07-07
07899258634388Orthopedic InstrumentsSCREW EXTRACTOR 3.5mm169-4252026-07-07
07899258636290Orthopedic InstrumentsØ3.2mm WIRE CUTTING FORCEPS172-19A2026-07-07
07899258645094Orthopedic InstrumentsSCREW DRIVER TIP HEXALOBULAR T15 FIT AO307-1102026-07-07
07899258646527Orthopedic Instruments1.0x20.0x100.0mm GUIDE WIRE WITH SPHERICAL STOP223-3062026-07-07
07899258655864Orthopedic InstrumentsINSTRUMENTAL TRAY FOR ANKLE FRACTURE314-70022026-07-07
07899258655871Orthopedic InstrumentsIMPLANT TRAY TO ANKLE FRACTURE314-70042026-07-07
07899258655932Orthopedic InstrumentsVERSALOCK SYSTEM KIT FOR ANKLE314-70012026-07-07
07899258655949Orthopedic InstrumentsANKLE FRACTURE IMPLANT TRAY314-70032026-07-07
07899258656151Orthopedic InstrumentsIDENTIFICATION AND ORIENTATION PANEL314-70082026-07-07
07899258695464Orthopedic InstrumentsVERSA AND VERSALOCK SCREW CASES Ø2.7mm AND Ø3.5mm314-70052026-07-07
07899258695471Orthopedic InstrumentsMINI CANNULATED SCREW CASE Ø4.0mm AND DEDICATED IN314-70062026-07-07
07899258695488Orthopedic InstrumentsVERSALOCK MINI PLATE CASE314-70072026-07-07
07901125601130GMReis Suture AnchorsFASTLOCK - KNOTLESS PEEK ANCHOR Ø4.75x15.0/19.1mm 320-475191-PE3H2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258658230Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658247Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658254Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658261Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658278Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658285Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258638867Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
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07899258638898Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638911Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638928Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
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