FDA.reportPublic FDA data

RAZEK EQUIPAMENTOS

Primary DI
07908832530074
Brand
RAZEK EQUIPAMENTOS
Company
RAZEK EQUIPAMENTOS LTDA
Model
978861160
Device description
Razek Diamond Burrs - BHC180B (0,7)
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908832530074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908832530074079088325300747908832530074

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898213154
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
07908832573699RAZEK EQUIPAMENTOS7345900002024-12-06
07908832580888RAZEK EQUIPAMENTOS7321700032024-12-06
07908832572333RAZEK EQUIPAMENTOS7311000002024-12-05
07908832572340RAZEK EQUIPAMENTOS7311000012024-12-05
07908832572418RAZEK EQUIPAMENTOS7311400002024-12-05
07908832572425RAZEK EQUIPAMENTOS7311400012024-12-05
07908832572432RAZEK EQUIPAMENTOS7342100002024-12-05
07908832572449RAZEK EQUIPAMENTOS7342101002024-12-05
07908832572456RAZEK EQUIPAMENTOS7342200002024-12-05
07908832572463RAZEK EQUIPAMENTOS7342201002024-12-05
07908832572470RAZEK EQUIPAMENTOS7311500002024-12-05
07908832572487RAZEK EQUIPAMENTOS7311500012024-12-05
07908832572494RAZEK EQUIPAMENTOS7311600002024-12-05
07908832572500RAZEK EQUIPAMENTOS7311600012024-12-05
07908832572555RAZEK EQUIPAMENTOS7311900002024-12-05
07908832572562RAZEK EQUIPAMENTOS7311900012024-12-05
07908832572579RAZEK EQUIPAMENTOS7342300002024-12-05
07908832572586RAZEK EQUIPAMENTOS7342301002024-12-05
07908832572593RAZEK EQUIPAMENTOS7342400002024-12-05
07908832572609RAZEK EQUIPAMENTOS7342401002024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867550292Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550308Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
04054896000831Control GaugesSilony Medical GmbHLXH2026-09-18
04054896000855Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000862Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000879Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000886Forceps and ClampsSilony Medical GmbHLXH2026-09-18
04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18