FDA.reportPublic FDA data

Sterile Aspiration Tips

Primary DI
08052141312636
Brand
Sterile Aspiration Tips
Company
OMNIA SRL
Model
22.F6063.00
Device description
Cannula with ergonomic handle without suction control (Tip length cm 15)
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
08052141312636PrimaryGS10
08052141312643Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052141312636080521413126368052141312636
08052141312643080521413126438052141312643

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
00841709122286MidmarkMIDMARK CORPORATIONEBR2026-02-20
06971119541910Suction machineGuangdong JINME Medical Technology Co., Ltd.EBR2025-07-15
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
00810032660802Isolite, i3ZYRIS, INC.EBR2024-04-19
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
00810032660888Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660901Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660925Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660932Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660949Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660956Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660963Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660970IsovacZYRIS, INC.EBR2024-04-19
00810032660987Anterior MouthpieceZYRIS, INC.EBR2024-04-19
00810032661007Anterior Hose KitZYRIS, INC.EBR2024-04-19
00810032661014Operating Room AdapterZYRIS, INC.EBR2024-04-19