FDA.reportPublic FDA data

Suction tip

Primary DI
08033178018647
Brand
Suction tip
Company
SORIN GROUP ITALIA SRL
Model
SU-10101
Published
2024-04-04
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
DTSSucker, cardiotomy return, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTSSucker, Cardiotomy Return, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178018648PackageGS110In Commercial Distribution
08033178018647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317801864838033178018648
08033178018647080331780186478033178018647

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Regulatory Flags#

DUNS number
442126587
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178018203Venous Cardiopolmunary Bypass CannulaRDS-610342025-12-19
08033178018227Venous Cardiopolmunary Bypass CannulaRDS-610402025-12-19
08033178018234Venous Cardiopolmunary Bypass CannulaRDS-610462025-12-19
08033178018258Venous Cardiopolmunary Bypass CannulaRDS-611342025-12-19
08033178018272Venous Cardiopolmunary Bypass CannulaRDS-611402025-12-19
08033178018289Venous Cardiopolmunary Bypass CannulaRDS-611462025-12-19
08033178018296Venous Cardiopolmunary Bypass CannulaRDS-611502025-12-19
08033178018364Venous Cardiopolmunary Bypass CannulaRV-400162025-12-19
08033178018371Venous Cardiopolmunary Bypass CannulaRV-400182025-12-19
08033178018388Venous Cardiopolmunary Bypass CannulaRV-400202025-12-19
08033178018395Venous Cardiopolmunary Bypass CannulaRV-400222025-12-19
08033178018401Venous Cardiopolmunary Bypass CannulaRV-400242025-12-19
08033178018418Venous Cardiopolmunary Bypass CannulaRV-400262025-12-19
08033178018425Venous Cardiopolmunary Bypass CannulaRV-400282025-12-19
08033178018432Venous Cardiopolmunary Bypass CannulaRV-400302025-12-19
08033178018449Venous Cardiopolmunary Bypass CannulaRV-400322025-12-19
08033178018456Venous Cardiopolmunary Bypass CannulaRV-400342025-12-19
08033178018463Venous Cardiopolmunary Bypass CannulaRV-400362025-12-19
08033178018487Venous Cardiopolmunary Bypass CannulaRV-405362025-12-19
08033178018524Venous Cardiopolmunary Bypass CannulaRV-410182025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841742149356HNM MedicalHNM STAINLESS, LLC.DTS2025-01-27
10841742149353HNM MedicalHNM STAINLESS, LLC.DTS2025-01-27
08033178018654Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018661Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018678Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018708Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018715Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018722Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018739Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018746Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018648Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018655Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018662Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018679Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018709Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018716Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018723Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018730Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018747Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018753Suction tipSORIN GROUP ITALIA SRLDTS2024-03-20
38033178018754Suction tipSORIN GROUP ITALIA SRLDTS2024-03-20
00842962106426HNM MedicalHNM STAINLESS, LLC.DTS2024-02-09
05060660971510TEMEDTemedDTS2023-06-14
05060660971503TEMEDTemedDTS2023-06-14
05060660971749TEMEDTemedDTS2023-06-14
00818354013955ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
00818354013962ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
B0662010350000ADULT GROOVED TIP SUCKERNOVOSCI CORP.DTS2016-09-26
B0662010360000Pediatric Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662010370000INFANT GROOVED TIP SUCKERNOVOSCI CORP.DTS2016-09-26