Duo Venous Stent System N1101412009120

GUDID 00810010693457

Duo Hybrid Venous Stent System, 14mm x 120mm Stent, 9F x 120cm Delivery System

Vesper Medical Inc

Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent Iliofemoral vein stent

Primary Device ID	00810010693457
NIH Device Record Key	19d1aae0-6f12-42e1-8649-cc4131359b48
Commercial Distribution Status	In Commercial Distribution
Brand Name	Duo Venous Stent System
Version Model Number	N1101412009120
Catalog Number	N1101412009120
Company DUNS	080441571
Company Name	Vesper Medical Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810010693457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230021

FDA Product Code

QAN	Stent, Iliac Vein

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-09
Device Publish Date	2024-05-01

On-Brand Devices [Duo Venous Stent System]

00810010694898	Duo Hybrid Venous Stent System, 18mm x 120mm Stent, 10F x 120cm Delivery System
00810010694850	Duo Hybrid Venous Stent System, 16mm x 160mm Stent, 10F x 120cm Delivery System
00810010694843	Duo Hybrid Venous Stent System, 16mm x 140mm Stent, 10F x 120cm Delivery System
00810010694836	Duo Hybrid Venous Stent System, 16mm x 120mm Stent, 10F x 120cm Delivery System
00810010694829	Duo Hybrid Venous Stent System, 16mm x 100mm Stent, 10F x 120cm Delivery System
00810010694782	Duo Extend Venous Stent System, 16mm x 120mm Stent, 10F x 120cm Delivery System
00810010693471	Duo Hybrid Venous Stent System, 14mm x 160mm Stent, 9F x 120cm Delivery System
00810010693464	Duo Hybrid Venous Stent System, 14mm x 140mm Stent, 9F x 120cm Delivery System
00810010693457	Duo Hybrid Venous Stent System, 14mm x 120mm Stent, 9F x 120cm Delivery System
00810010693440	Duo Hybrid Venous Stent System, 14mm x 100mm Stent, 9F x 120cm Delivery System
00810010693341	Duo Extend Venous Stent System, 14mm x 120mm Stent, 9F x 120cm Delivery System
00810010693327	Duo Extend Venous Stent System, 14mm x 80mm Stent, 9F x 120cm Delivery System
00810010693280	Duo Extend Venous Stent System, 12mm x 120mm Stent, 9F x 120cm Delivery System
00810010693266	Duo Extend Venous Stent System, 12mm x 80mm Stent, 9F x 120cm Delivery System