FDA.reportPublic FDA data

Surgical aspirator 2.20 m with cannula Yankauer without aspiration control

Primary DI
08052141312353
Brand
Surgical aspirator 2.20 m with cannula Yankauer without aspiration control
Company
OMNIA SRL
Model
32.F2046.00
Device description
Surgical aspirator 2.20 m with cannula Yankauer without aspiration control
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBRUnit, Suction Operatory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052141312353PrimaryGS10
08052141312360Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052141312353080521413123538052141312353
08052141312360080521413123608052141312360

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Regulatory Flags#

DUNS number
447696675
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052141311806Irrigation Line32.F0139.002026-03-27
08052141312025Irrigation Line32.F0170.002026-03-27
08052141312780Irrigation Line32.F0006.002026-03-27
08052141312865Irrigation Line32.F0134.002026-03-27
08052141312940Irrigation Line32.F0161.002026-03-27
08052141313602Irrigation Line32.F0105.002026-03-27
08056646500291Basic Implant Set12.S5621.002026-03-27
08056646500307Implantology Set12.S4671.002026-03-27
08056646500321Oral Surgery Set12.S4096.002026-03-27
08056646500482Oral Surgery Pack12.S8318.00 2026-03-27
08056646508846Adhesive Films32.U0020.002026-03-27
08056646508945Adhesive Films32.U4020.002026-03-27
08056646503018Sterile PTFE Surgical Suture32.Z4400.002017-02-27
08056646500017Sterile PTFE Surgical Suture32.Z3130.002016-05-31
08056646500031Sterile PTFE Surgical Suture32.Z3141.002016-07-07
08056646500055Sterile PTFE Surgical Suture32.Z3150.002016-08-29
08056646500079Sterile PTFE Surgical Suture32.Z3160.002016-08-29
08056646500086Sterile PTFE Surgical Suture32.Z3151.002016-08-29
08056646500116Sterile PTFE Surgical Suture32.Z3260.002016-08-29
08056646500123Sterile PTFE Surgical Suture32.Z3240.002016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07898938244220MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244237MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244732MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
00810032660710Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660758Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660765Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660772Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660789Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660796Isolite, i3ZYRIS, INC.EBR2024-04-19
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00810032660819Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660826Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660833Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660840Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660857Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660864Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660871Isolite, i3ZYRIS, INC.EBR2024-04-19
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00810032660932Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660949Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660956Isolite, i3ZYRIS, INC.EBR2024-04-19
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00810032660987Anterior MouthpieceZYRIS, INC.EBR2024-04-19
00810032661007Anterior Hose KitZYRIS, INC.EBR2024-04-19
00810032661014Operating Room AdapterZYRIS, INC.EBR2024-04-19