FDA.reportPublic FDA data

RAZEK EQUIPAMENTOS

Primary DI
07908832531163
Brand
RAZEK EQUIPAMENTOS
Company
RAZEK EQUIPAMENTOS LTDA
Model
978871490
Device description
Razek Diamond Burrs - BHC115K (4,5)
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
07908832531163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908832531163079088325311637908832531163

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
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900039EARP FINAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900152EARP CRADLE ASSEMBLYRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900299EARP, TRIAL 22X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15