FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919413097
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001787U0
Device description
10000 RONGEUR 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00887919413097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919413097008879194130978879194130970887919413097

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating 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 that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
08404535024258Axiom BladesBRAXM-FP14MBRAXM-FP14M2026-04-29
08404535024289Axiom BladesBRAXM-FC6BRAXM-FC62026-04-29
08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024340Axiom BladesBRAXM-HP8SBRAXM-HP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29

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