FDA.reportPublic FDA data

NeoZoline

Primary DI
09421901970253
Brand
NeoZoline
Company
ADEPT MEDICAL LIMITED
Model
NZ3220-2
Catalog number
NZ3220-2
Device description
Vent Tube Collar Button - Double
Published
2016-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETDTube, Tympanostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061058000NEOZOLINE VENTILATION TUBESAdept Medical, Ltd.2006-07-12ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421901970253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421901970253094219019702539421901970253

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Regulatory Flags#

DUNS number
592534619
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421901970345NeoZolineNZ3306NZ33062016-02-25
09421901970352NeoZolineNZ3306-2NZ3306-22016-02-25
09421901970369NeoZolineNZ3309NZ33092016-02-25
09421901970376NeoZolineNZ3309-2NZ3309-22016-02-25
09421901970383NeoZolineNZ3312NZ33122016-02-25
09421901970390NeoZolineNZ3312-2NZ3312-22016-02-25
09421901970406NeoZolineNZ3321NZ33212016-02-25
09421901970413NeoZolineNZ3321-2NZ3321-22016-02-25
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionAM0460AM04602026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowAM0470AM04702026-02-09
09421902825927Arm StrapsAM0620AM06202018-05-24
09421902825491Adept Medical Femoral TableAM0300AM03002017-05-29
09421902825880IR ShieldAM0500AM05002017-11-24
09421902825941Adept Medical Drape SupportAM1000AM10002018-07-25
09421905187374Adept Medical ArmSureAM0640AM06402024-03-20
09421905187435Adept Medical STARTableDAM0140D2024-02-15
09421905187558Adept Medical Arm Support PadAAM01712022-10-13
09421905187589Adept Medical Drape SupportBAM1000B2022-10-13
09421902825712Adept Medical STARTableAM0140CAM0140C2017-05-29
09421902825934Arm Sure ShieldAM0630AM06302018-05-24

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Primary DI, Brand, Company table
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