FDA.reportPublic FDA data

American Medicals

Primary DI
B356KB013000
Brand
American Medicals
Company
American Medicals
Model
1
Published
2026-11-03
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

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
B356KB013000PrimaryHIBCC0

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B35671626000American Medicals12026-11-02
B3567162600250American Medicals12026-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437541MillenniumAvalign Technologies, Inc.GEN2026-11-04
00190776437558MillenniumAvalign Technologies, Inc.GEN2026-11-04
00190776437619MillenniumAvalign Technologies, Inc.GEN2026-11-04
B382SD402590Surgical DirectSurgical Direct, Inc.GEN2026-11-03
00850090726003Intrace USAPILOTIS TECH LLCGEN2026-10-31
00850090726010Intrace USAPILOTIS TECH LLCGEN2026-10-31
00850090726027Intrace USAPILOTIS TECH LLCGEN2026-10-31
G383S1085WM7786614SURJEXSURJEXGEN2026-10-31
G383S1085WM77866155SURJEXSURJEXGEN2026-10-31
G383S1092WM0202S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0205S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0220S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0405S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0413S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0418S3M4SURJEXSURJEXGEN2026-10-31
G383S1092WM0914S3N7SURJEXSURJEXGEN2026-10-31
G383S1092WM0948S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0958S3SURJEXSURJEXGEN2026-10-31
G383S1092WM1025615SURJEXSURJEXGEN2026-10-31
G383S1092WWM0313S3SURJEXSURJEXGEN2026-10-31
G383S1092WWM0315S3SURJEXSURJEXGEN2026-10-31
G383S109317410S4SURJEXSURJEXGEN2026-10-31
G383S1093WM3197476SURJEXSURJEXGEN2026-10-31
G383S1094WM0958S3R5SURJEXSURJEXGEN2026-10-31
G383S1094WM77866055SURJEXSURJEXGEN2026-10-31
G383S1098WM1325320SURJEXSURJEXGEN2026-10-31
G383S1098WM1325324SURJEXSURJEXGEN2026-10-31
G383S1098WM1325325SURJEXSURJEXGEN2026-10-31
G383S1098WM1325326SURJEXSURJEXGEN2026-10-31
G383S1098WM1325327SURJEXSURJEXGEN2026-10-31