FDA.reportPublic FDA data

American Medicals

Primary DI
B3564123819100
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3564123819100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
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
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356BK211150American Medicals12025-11-10
B356DF410180American Medicals12025-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386748701Orthopaedic Surgical InstrumentsCITIEFFE SRLHTO2026-05-27
08800017270265BENCOXCorentec Co., LtdHTO2026-04-02
08800017270272BENCOXCorentec Co., LtdHTO2026-04-02
08800017270289BENCOXCorentec Co., LtdHTO2026-04-02
08800017270296BENCOXCorentec Co., LtdHTO2026-04-02
08800017270302BENCOXCorentec Co., LtdHTO2026-04-02
08800017270319BENCOXCorentec Co., LtdHTO2026-04-02
08800017270326BENCOXCorentec Co., LtdHTO2026-04-02
08800017270333BENCOXCorentec Co., LtdHTO2026-04-02
08800017270340BENCOXCorentec Co., LtdHTO2026-04-02
08800017270364BENCOXCorentec Co., LtdHTO2026-04-02
08800017270388BENCOXCorentec Co., LtdHTO2026-04-02
08800017270401BENCOXCorentec Co., LtdHTO2026-04-02
08800017270425BENCOXCorentec Co., LtdHTO2026-04-02
08800017270449BENCOXCorentec Co., LtdHTO2026-04-02
08800017270463BENCOXCorentec Co., LtdHTO2026-04-02
08800017270470BENCOXCorentec Co., LtdHTO2026-04-02
08800017270487BENCOXCorentec Co., LtdHTO2026-04-02
08800017270500BENCOXCorentec Co., LtdHTO2026-04-02
08800017270524BENCOXCorentec Co., LtdHTO2026-04-02
08800017270548BENCOXCorentec Co., LtdHTO2026-04-02
08800017270562BENCOXCorentec Co., LtdHTO2026-04-02
08800017270579BENCOXCorentec Co., LtdHTO2026-04-02
08800017270586BENCOXCorentec Co., LtdHTO2026-04-02
08800017270593BENCOXCorentec Co., LtdHTO2026-04-02
08800017270609BENCOXCorentec Co., LtdHTO2026-04-02
08800017270616BENCOXCorentec Co., LtdHTO2026-04-02
08800017270623BENCOXCorentec Co., LtdHTO2026-04-02
07640187918410TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBSMPS Micro Precision Systems AGHTO2026-02-24
G079C5090000070Golden Isles Pedicle Screw SystemIntelivation, LLCHTO2022-09-23