FDA.reportPublic FDA data

American Medicals

Primary DI
B356FF701020
Brand
American Medicals
Company
American Medicals
Model
1
Published
2026-07-14
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
GDNKnife, Amputation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356FF701020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Amputation knifeA hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument 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
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
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
B356FH455060American Medicals12025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B356BH414050American MedicalsAmerican MedicalsGDN2026-05-06
14026704941640PILLINGTELEFLEX INCORPORATEDGDN2026-03-23
24026704941647PILLINGTELEFLEX INCORPORATEDGDN2026-03-23
14026704941657PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
24026704941654PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
08403207009500Anmuth Medical InternationalAnmuth Medical International, LLCGDN2025-06-09
00840343725563GEN2SURGIX MEDICAL LLCGDN2025-02-11
B356EE173000American MedicalsAmerican MedicalsGDN2024-11-12
04049197022613RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022637RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022644RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022651RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022668RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022675RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197410540RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
B356126CL120American MedicalsAmerican MedicalsGDN2024-05-14
G586N91281280Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
G586N91281310Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
00190776062033AvalignAvalign Technologies, Inc.GDN2023-09-28
00190776289218MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
00190776343408MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
B356BH420280American MedicalsAmerican MedicalsGDN2023-09-28
00810123205929Adler Instrument CompanyAdler, Inc.GDN2023-06-16
00842962107140HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842962160565HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842331143984Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-11
00842331134623Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-10
B35607423200American MedicalsAmerican MedicalsGDN2022-09-21
B35607423240American MedicalsAmerican MedicalsGDN2022-09-21
B356BH420130American MedicalsAmerican MedicalsGDN2022-09-16