FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685636530
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
56-3653
Catalog number
56-3653
Device description
Rongeur,DA,SqCup,strng cv,3mm
Published
2024-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMHForceps, Rongeur, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685636530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
808385207
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7681901210Buxton BioMedical190-121190-1212023-07-07
B7683439140Buxton BioMedical34-391434-39142026-04-24
B7685674460Buxton BioMedical56-744656-74462026-04-24
B7685676080Buxton BioMedical56-760856-76082026-04-24
B7685677060Buxton BioMedical56-770656-77062026-04-24
B7682462200Buxton BioMedical24-622024-62202026-04-23
B7683434130Buxton BioMedical34-341334-34132026-04-23
B7687417000Buxton BioMedical74-170074-17002026-04-23
B7687684070Buxton BioMedical76-840776-84072026-04-23
B7688386020Buxton BioMedical83-860283-86022026-04-23
B7688441030Buxton BioMedical84-410384-41032026-04-23
B76884751040Buxton BioMedical847-5104847-51042026-04-23
B76884754320Buxton BioMedical847-5432847-54322026-04-23
B7688532061030Buxton BioMedical853-20-6103853-20-61032026-04-23
B7688532351120Buxton BioMedical853-23-5112853-23-51122026-04-23
B7688532351130Buxton BioMedical853-23-5113853-23-51132026-04-23
B7688650540Buxton BioMedical86-505486-50542026-04-23
B7688441020Buxton BioMedical84-410284-41022025-12-31
B7688457751630Buxton BioMedical845-77-5163845-77-51632025-12-31
B76885362280Buxton BioMedical853-6228853-62282025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7330TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7340TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7350TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7360TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149NP380640NPSACME ENTERPRISE.EMH2026-05-01
B7688386020Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688441030Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B76884751040Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B76884754320Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532061030Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532351120Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532351130Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688650540Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
00810158219229PRINCETONPrinceton Medical Group, Inc.EMH2026-03-12
00810158219076PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219083PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MMW.H. Holden, Inc.EMH2026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MMW.H. Holden, Inc.EMH2026-01-06
B7688441020Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B7688457751630Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362280Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362360Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
08809596474019Kerrison Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
B7688457751030Buxton BioMedicalBuxton Biomedical IncEMH2025-11-21