FDA.reportPublic FDA data

SOLENT DISTA

Primary DI
00616258005089
Brand
SOLENT DISTA
Company
Bayer Healthcare LLC
Model
111303-001
Catalog number
111303
Device description
SOLENT DISTA, FG PKG
Published
2014-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616258005089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616258005089006162580050896162580050890616258005089

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-780-4555michael.burnside@bayer.com

Regulatory Flags#

DUNS number
079415074
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888853030517EssureESS305-R12014-09-04
10888853003051EssureESS3052014-09-04
20888853003058EssureESS305 (Kit)2014-09-04
00616258003832AVX105039-0011050392014-10-09
00616258003849XVG105042-0011050422014-10-09
00616258003856SPIROFLEX VG106608-0011066082014-10-07
00616258003887SPIROFLEX106553-0011065532014-10-09
00616258003894XMI105041-0011050412014-10-07
00616258003917SOLENT PROXI109676-0011096762014-10-09
00616258003924SOLENT OMNI 109681-0011096812014-10-07
00616258003955FETCH 2109400-0011094002014-10-09
00616258005096DISTAFLEX111304-0011113042014-10-07
00616258005164JETWIRE011525-0010115252015-02-27
00311017405307Dr. Scholl's 16121712016-09-01
00311017405321Dr. Scholl's 16121712016-09-01
00311017405345Dr. Scholl's 16121712016-09-01
00011017576983Dr. Scholl's 16121712018-02-12
10311017405304Dr. Scholl's 16121712016-09-01
00016500574057Aleve16135382017-09-01
00325866565044Aleve 16135382016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
10801902196603ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
10801902194043ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194050ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194067ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194074ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194081ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194098ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194104ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08