FDA.reportPublic FDA data

American Medicals

Primary DI
B356ED107160
Brand
American Medicals
Company
American Medicals
Model
1
Published
2025-12-03
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
B356ED107160PrimaryHIBCC0

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
Microwave Radiation

Regulatory Flags#

DUNS number
109909627
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B35665124160American Medicals12026-09-25
B356KD905230American Medicals12026-09-25
B356KD910090American Medicals12026-09-25
B356FF192040American Medicals12022-09-26
B35645724070American Medicals12022-09-09
B356FF701020American Medicals12026-07-14
B356JB405140American Medicals12026-07-06
B356BK211110American Medicals12026-05-29
B356KE392100American Medicals12026-05-29
B356KE396100American Medicals12026-05-29
B35675400020American Medicals12026-05-20
B35675440110American Medicals12026-05-20
B356BH414050American Medicals12026-05-06
B356KB074090American Medicals12026-05-06
B356KF251020American Medicals12026-04-15
B356KF251040American Medicals12026-04-15
B356ED469970American Medicals12026-04-07
B356ED470040American Medicals12026-04-07
B356ED470050American Medicals12026-04-07
B356JD259280American Medicals12026-03-09

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