FDA.reportPublic FDA data

American Medicals

Primary DI
B35628130230
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B35628130230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer transfer forcepsA hand-held, scissors-like, manual surgical instrument whose blades, distal to the pivot point, form open circles, loops, or ellipses designed to grasp and handle sterile instruments, packages, or implants, especially directly from a sterilizer. It is typically made of high-grade stainless steel. 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
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422721MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422769MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422790MillenniumAvalign Technologies, Inc.GEN2026-08-03
B382SD4829170Surgical DirectSurgical Direct, Inc.GEN2026-08-03
00190776422141MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422226MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422233MillenniumAvalign Technologies, Inc.GEN2026-07-31
B382SD1426525010Surgical DirectSurgical Direct, Inc.GEN2026-07-31
B382SD1426525020Surgical DirectSurgical Direct, Inc.GEN2026-07-31
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934891SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935362SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935379SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935546SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935553SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935560SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935584SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935591SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935669SURGIPROSSurgipros, LLCGEN2026-07-30
B382SD919327220Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919327230Surgical DirectSurgical Direct, Inc.GEN2026-07-29