FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955BGM0011
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
BGC001
Device description
PAUL BANDITT BONE GRAFT CRUSHER
Published
2023-12-11
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
D955BGM0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual bone millA manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95516CASS1Paul Banditt16CASS2026-09-25
D9555CASS1Paul Banditt5CASS2026-09-25
D9558CASS1Paul Banditt8CASS2026-09-25
D955BBCG35450Paul BandittBBCG35452026-09-25
D955BBGA351Paul BandittBBGA352026-09-25
D955BBGA451Paul BandittBBGA452026-09-25
D955BBGA551Paul BandittBBGA552026-09-25
D955BBGA701Paul BandittBBGA702026-09-25
D955BDT11Paul BandittBDT12026-09-25
D955BDT21Paul BandittBDT22026-09-25
D955BDT31Paul BandittBDT32026-09-25
D955BDT61Paul BandittBDT62026-09-25
D955BDT71Paul BandittBDT72026-09-25
D955BDT81Paul BandittBDT82026-09-25
D955BDT91Paul BandittBDT92026-09-25
D955BLAHST1Paul BandittBLAHST2026-09-25
D955BMDG010Paul BandittBMDG-012026-09-25
D955BMDG021Paul BandittBMDG-022026-09-25
D955BMDG031Paul BandittBMDG-032026-09-25
D955BONDNG1Paul BandittBONDNG2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955RON811S1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONBLU1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONMC0Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
B76884850220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-05
B7685631130Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688371010Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688386020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884751040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884754320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751630Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-21
B76884332520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-13
B7688452420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-03
B76884850320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B7685636870Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B7685636880Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B76884342320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B76884342420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B7688365450Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7688439220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7685638140Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688378040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688457651620Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-07