FDA.reportPublic FDA data

American Medicals

Primary DI
B356BK831120
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356BK831120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT wire-cutting scissorsA hand-held manual surgical instrument designed to cut wire intended to construct ossicular replacements for the middle ear. The cutting blades will be more robust than ordinary scissors to tolerate the forces required to cut surgical wire. 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
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
09348811003119INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-03-18
09348811000798INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000804INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000842INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000859INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000866INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811153494INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811173058INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
10198956213302CARDINAL HEALTHCardinal Health 200, LLCLRW2025-11-24
09348811000811INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001313INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001702INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811002433INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003171INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003805INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811007117INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
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G453CA433700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA435700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA455660PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA463680PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21