Duo Hybrid Venous Stent System

Primary DI
00810010693457
Brand
Duo Hybrid Venous Stent System
Company
Vesper Medical, Inc.
Model
N1101412009120
Catalog number
N1101412009120
Device description
Duo Hybrid Venous Stent System, 14mm x 120mm Stent, 9F x 120cm Delivery System
Published
2024-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QANStent, Iliac Vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QANStent, Iliac VeinUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230021000Duo Venous Stent SystemPhilips Image Guided Therapy Corporation2023-12-26QAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810010693457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010693457008100106934578100106934570810010693457

GMDN Terms#

Term, Definition table
TermDefinition
Iliofemoral vein stentA non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080441571
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810010693266Duo Extend Venous Stent SystemN1201208009120N12012080091202024-05-01
00810010693280Duo Extend Venous Stent SystemN1201212009120N12012120091202024-05-01
00810010693327Duo Extend Venous Stent SystemN1201408009120N12014080091202024-05-01
00810010693341Duo Extend Venous Stent SystemN1201412009120N12014120091202024-05-01
00810010693440Duo Hybrid Venous Stent SystemN1101410009120N11014100091202024-05-01
00810010693464Duo Hybrid Venous Stent SystemN1101414009120N11014140091202024-05-01
00810010693471Duo Hybrid Venous Stent SystemN1101416009120N11014160091202024-05-01
00810010694782Duo Extend Venous Stent SystemN1201612010120N12016120101202024-05-01
00810010694829Duo Hybrid Venous Stent SystemN1101610010120N11016100101202024-05-01
00810010694836Duo Hybrid Venous Stent SystemN1101612010120N11016120101202024-05-01
00810010694843Duo Hybrid Venous Stent SystemN1101614010120N11016140101202024-05-01
00810010694850Duo Hybrid Venous Stent SystemN1101616010120N11016160101202024-05-01
00810010694898Duo Hybrid Venous Stent SystemN1101812010120N11018120101202024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010693266Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693280Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693327Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693341Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693440Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693464Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010693471Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694782Duo Extend Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694829Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694836Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694843Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694850Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
00810010694898Duo Hybrid Venous Stent SystemVesper Medical, Inc.QAN2024-05-01
10827002574295Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574301Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574318Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574325Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574332Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574349Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574356Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574363Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574370Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574387Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574394Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574400Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574417Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574424Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574431Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574448Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574455Zilver VenaCOOK IRELAND LTDQAN2020-11-04