FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B3568851100PrimaryHIBCC0

GMDN Terms

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
Microwave Radiation

Regulatory Flags

DUNS number
109909627
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
B356KD932040American Medicals12025-09-18
B356KD932070American Medicals12025-09-18
B356KE334280American Medicals12025-09-15
B356KJ522130American Medicals12025-09-12
B356FF131030American Medicals12025-08-16
B356FF131050American Medicals12025-08-16
B356KE292350American Medicals12025-08-15
B356KE295040American Medicals12025-08-15
B356KE296030American Medicals12025-08-15
B356KE312070American Medicals12025-08-15
B356KE328060American Medicals12025-08-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810220800003Adler Instrument CompanyAdler, Inc.LRW2026-03-17
00810158219366PRINCETONPrinceton Medical Group, Inc.LRW2026-03-12
00190776394127MillenniumAvalign Technologies, Inc.LRW2026-03-11
00190776417833MillenniumAvalign Technologies, Inc.LRW2026-03-11
00810158218987PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158218994PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158219168PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00192896122734Metzenbaum ScissorsSONTEC INSTRUMENTS, INC.LRW2026-03-10
04058749117462NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749121995NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749122008NAFehling Instruments GmbH & Co. KGLRW2026-03-05
00198506088605ELMED INCORPORATEDELMED INCORPORATEDLRW2026-02-23
00190776417277MillenniumAvalign Technologies, Inc.LRW2026-02-20
00190776417291MillenniumAvalign Technologies, Inc.LRW2026-02-20
00810058670540ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810058670557ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810058670564ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810097677043ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00840306837340Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00840306837357Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00810097676947ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676954ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676961ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676978ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
G4254009010My MedicalMy Medical Store LLCLRW2026-02-17
G425400913SCP0My MedicalMy Medical Store LLCLRW2026-02-17
00810158218918PRINCETONPrinceton Medical Group, Inc.LRW2026-02-16
04059453062468Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-02-13
09348811000873INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13
09348811000897INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13