NeoZoline NZ3122

GUDID 09421901970062

Vent Tube Armstrong Tail

ADEPT MEDICAL LIMITED

Tympanostomy tube
Primary Device ID09421901970062
NIH Device Record Keyb3c3f73a-c3d8-4c3b-b586-a0fa98a5e8a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoZoline
Version Model NumberNZ3122
Catalog NumberNZ3122
Company DUNS592534619
Company NameADEPT MEDICAL LIMITED
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421901970062 [Primary]
GS109421902825606 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTube, Tympanostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-22
Device Publish Date2016-01-13

On-Brand Devices [NeoZoline]

09421901970154Vent Tube Straight Tube - Double
09421901970147Vent Tube Straight Tube
09421901970130Vent Tube Bevel Bobbin - Double
09421901970123Vent Tube Bevel Bobbin
09421901970116Vent Tube Mod Armstrong Tail - Double
09421901970109Vent Tube Mod Armstrong - Tail
09421901970093Vent Tube Mod Armstrong - Double
09421901970086Vent Tube Mod Armstrong
09421901970079Vent Tube Armstrong Tail - Double
09421901970062Vent Tube Armstrong Tail
09421901970048Vent Tube Armstrong
09421901970031Vent Tube Collar Button Tail - Double
09421901970024Vent Tube Collar Button Tail
09421901970017Vent Tube Collar Button Double
09421901970000Vent Tube Collar Button
09421901970451Jobson Horne Probe

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.