FDA.reportPublic FDA data

RAZEK EQUIPAMENTOS

Primary DI
07908832572418
Brand
RAZEK EQUIPAMENTOS
Company
RAZEK EQUIPAMENTOS LTDA
Model
731140000
Device description
Razek Surgical Burrs - FAD125R (5,0)
Published
2024-12-05
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
07908832572418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908832572418079088325724187908832572418

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
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
07908832572616RAZEK EQUIPAMENTOS7312000002024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02
07630894822582APTUSMedartis AGLXH2026-11-02
07630894822599APTUSMedartis AGLXH2026-11-02
07630894822629APTUSMedartis AGLXH2026-11-02
07630894822636APTUSMedartis AGLXH2026-11-02
07630894822643APTUSMedartis AGLXH2026-11-02
07630894822650APTUSMedartis AGLXH2026-11-02
07630894822681APTUSMedartis AGLXH2026-11-02
07630894823787APTUSMedartis AGLXH2026-11-02
00824846010746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00824846010753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00810017915446Pituitary Straight, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915453Pituitary Straight, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017915460Kerrison, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915477Kerrison, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017916085SABER-XA Angled Self-Retaining Driver, No. 20 HexalobeELEVATION SPINE, INC.LXH2026-10-30
00811382039348NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
03700569680121Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
03700569680138Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
B382SD9144842000Surgical DirectSurgical Direct, Inc.LXH2026-10-30