FDA.reportPublic FDA data

American Medical

Primary DI
B356FH454070
Brand
American Medical
Company
American Medicals
Model
1
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZOChisel, Surgical, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356FH454070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
04054896001753ChiselSilony Medical GmbHFZO2026-09-18
04054896001760ChiselSilony Medical GmbHFZO2026-09-18
04054896001777ChiselSilony Medical GmbHFZO2026-09-18
04054896005751ChiselSilony Medical GmbHFZO2026-09-18
04054896018430ChiselSilony Medical GmbHFZO2026-09-18
04054896018447ChiselSilony Medical GmbHFZO2026-09-18
04054896050652ChiselSilony Medical GmbHFZO2026-09-18
04054896050669ChiselSilony Medical GmbHFZO2026-09-18
04054896050676ChiselSilony Medical GmbHFZO2026-09-18
04054896050683ChiselSilony Medical GmbHFZO2026-09-18
04054896050690ChiselSilony Medical GmbHFZO2026-09-18
04054896050706ChiselSilony Medical GmbHFZO2026-09-18
04054896051284ChiselSilony Medical GmbHFZO2026-09-18
04054462907663evonosevonos GmbH & Co. KGFZO2026-08-21
04054462912162evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912179evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912803evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912810evonosevonos GmbH & Co. KGFZO2026-08-19
04054462905416evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905423evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905430evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905447evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905461evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905478evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905485evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905492evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905508evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905515evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905522evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907632evonosevonos GmbH & Co. KGFZO2026-08-18