FDA.report

Percutaneous Foot Burrs, Arthodesis Burrs

Primary DI
07899258658261
Brand
Percutaneous Foot Burrs, Arthodesis Burrs
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Burrs Cylindrical
Catalog number
317-32
Device description
ARTHRODESEIS MINI BURRS CYLINDRICAL Ø4.0x16.0mm
Published
2024-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HTTBurr, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258658261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899258658261078992586582617899258658261

GMDN Terms

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

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

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07899258639062Orthopedic InstrumentsPeriostum 4.0mm Straight Tip900-992026-02-20
07899258648057Orthopedic InstrumentsHOHMANN SEPARATOR 8.0mm900-1012026-02-20
07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
07899258660929Orthopedic InstrumentsHex wrench 4.0353-109-10352026-02-20
07899258660936Orthopedic Instruments3.5 hex wrench353-109-10362026-02-20
07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
07899258660950Orthopedic Instruments2.5 Hex Wrench353-109-10382026-02-20
07899258660967Orthopedic InstrumentsHex wrench 2.0353-109-10392026-02-20
07899258660974Orthopedic InstrumentsHex wrench 1.5353-109-10402026-02-20
07899258660981Orthopedic Instruments5.0 Hex wrench353-109-10332026-02-20
07899258660998Orthopedic Instruments5.5 Hex Wrench353-109-10322026-02-20
07899258694702Orthopedic InstrumentsTorxdrive Wrench T20353-109-10222026-02-20
07899258694719Orthopedic InstrumentsTorxdrive Wrench T18353-109-10232026-02-20

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