FDA.reportPublic FDA data

American Medicals

Primary DI
B35644101030
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B35644101030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal material application syringe/cannulaA device consisting of a barrel (cylinder) with plunger and a permanently attached blunt cannula intended for the application of a liquid/semi-liquid material/pharmaceutical (e.g., corticosteroid or antibiotic cream, local anaesthetic agent) into the external auditory canal, as part of a treatment or during a procedure. This is a single-use 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
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
B356ED469970American Medicals12026-04-07
B356ED470040American Medicals12026-04-07
B356ED470050American Medicals12026-04-07
B356JD259280American Medicals12026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
04054462901975evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901982evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901999evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902002evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902019evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902026evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902033evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902040evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902057evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902064evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902088evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902095evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902118evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902125evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902132evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902149evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904396evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904402evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21