NeoZoline NZ3111-2

GUDID 09421901970017

Vent Tube Collar Button Double

ADEPT MEDICAL LIMITED

Tympanostomy tube
Primary Device ID09421901970017
NIH Device Record Key09a30070-2d22-44e9-9332-17aad2c87ddf
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoZoline
Version Model NumberNZ3111-2
Catalog NumberNZ3111-2
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
GS109421901970017 [Primary]
GS109421902825644 [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

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