FDA.reportPublic FDA data

American Medicals

Primary DI
B35668250040
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B35668250040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fistula probeA slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. 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
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092589ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092671ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092695ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092701ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092718ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092725ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093012ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093029ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093111ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093166ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093203ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093296ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093364ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093371ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093425ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093432ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093463ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092398ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092404ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092411ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22