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
B356111PL87514ST0steriSTAT12026-10-20
B356111OP918ST0American Medicals12022-12-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058749007039NAFehling Instruments GmbH & Co. KGLRW2026-10-23
04058749117509NAFehling Instruments GmbH & Co. KGLRW2026-10-23
00190776435639MillenniumAvalign Technologies, Inc.LRW2026-10-21
00190776436797MillenniumAvalign Technologies, Inc.LRW2026-10-21
00190776435479MillenniumAvalign Technologies, Inc.LRW2026-10-20
00190776436629MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776436728MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776439712MilleniumAvalign Technologies, Inc.LRW2026-10-20
B356111PL87514ST0steriSTATAmerican MedicalsLRW2026-10-20
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00840217905640Ebner MedicalEBNER MEDICAL, LLCLRW2025-04-03
00840217907408Ebner MedicalEBNER MEDICAL, LLCLRW2025-04-03
00840217907415Ebner MedicalEBNER MEDICAL, LLCLRW2025-04-03
00840217909471Ebner MedicalEBNER MEDICAL, LLCLRW2025-02-20
00840217909105Ebner MedicalEBNER MEDICAL, LLCLRW2024-09-23
00840217909068Ebner MedicalEBNER MEDICAL, LLCLRW2024-07-24
00840217909075Ebner MedicalEBNER MEDICAL, LLCLRW2024-07-24
00840217909051Ebner MedicalEBNER MEDICAL, LLCLRW2024-06-26
00840217908993Ebner MedicalEBNER MEDICAL, LLCLRW2024-04-11
00840217907972Ebner MedicalEBNER MEDICAL, LLCLRW2023-06-19
00840217907699Ace Medical CoEBNER MEDICAL, LLCLRW2023-03-06
00840217907569Ace Medical coEBNER MEDICAL, LLCLRW2023-01-24