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
New
Distribution status
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
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
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900865213
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
07899258650500Orthopedic InstrumentsREDUCTION FORCEPS JAW169-1652026-05-19
07899258699943Orthopedic InstrumentsT7 HEXALOBULAR DRIVER TIP 95mm223-308-F2026-05-19
07901125602502Orthopedic InstrumentsFRESA PARA PLACA DORSAL STT180-3802026-05-13
07901125602519Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 12F180-3812026-05-13
07901125602526Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 8F180-3822026-05-13
07899258601847Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x11.0mm223-24-11-BP2026-04-08
07899258601854Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x13.0mm223-24-13-BP2026-04-08
07899258601861Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x15.0mm223-24-15-BP2026-04-08
07899258601878Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x11.0mm223-24-11-C2026-04-08
07899258601885Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x13.0mm223-24-13-C2026-04-08
07899258601892Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x15.0mm223-24-15-C2026-04-08
07899258601908Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x11.0mm223-27-11-BP2026-04-08
07899258601915Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x13.0mm223-27-13-BP2026-04-08
07899258601922Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x15.0mm223-27-15-BP2026-04-08
07899258601939Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x11.0mm223-27-11-C2026-04-08
07899258601946Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x13.0mm223-27-13-C2026-04-08
07899258601953Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x15.0mm223-27-15-C2026-04-08
07899258612546Super Upper Limbs Versalock Plating SystemVERSALOCK TORXDRIVE MINI SCREW T6 Ø2.0x15.0mm308-20-15-B2026-04-08
07899258663500Super Upper Limbs Versalock Plating SystemVERSALOCK RADIUS SHAFT PLATE, VOLAR 160.0mm180-1122026-04-08
07899258663517Super Upper Limbs Versalock Plating SystemVERSALOCK RADIUS SHAFT PLATE, VOLAR 133.0mm180-1132026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809288930007IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930014IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
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08809288930038IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930045IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930052IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930069IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930076IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930083IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930090IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930106IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930113IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930120IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930137IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930144IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930151IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930168IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930175IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930182IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930199IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930205IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930212IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930229IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930236IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930243IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930250IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930267IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930274IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930281IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930298IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13