FDA.reportPublic FDA data

American Medicals

Primary DI
B3568851100
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-30
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
B3568851100PrimaryHIBCC0

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
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
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426651MillenniumAvalign Technologies, Inc.LRW2026-08-19
04054462913541evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913572evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913589evonosevonos GmbH & Co. KGLRW2026-08-19
00190776426392MillenniumAvalign Technologies, Inc.LRW2026-08-18
00198506094149ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094156ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094163ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
04054462903252evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903269evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903276evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903283evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903306evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903320evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903337evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903344evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903351evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903368evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903375evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903382evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903399evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904648evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904662evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904686evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904693evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904709evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904716evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904730evonosevonos GmbH & Co. KGLRW2026-08-18
04054462907908evonosevonos GmbH & Co. KGLRW2026-08-18
04054462908271evonosevonos GmbH & Co. KGLRW2026-08-18