AccessGUDID - DEVICE: TORUS Stent Graft System (00860008946423)

GUDID

Device Identifier (DI) Information

Brand Name: TORUS Stent Graft System
Version or Model: TSG-6.0X100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSG-6.0X100
Company Name: PQ Bypass, Inc.

Primary DI Number: 00860008946423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050620329 *Terms of Use

Device Description: The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61856	Central/peripheral venous endovascular stent-graft	A non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QWM	Stent Graft, Bypass, Superficial Femoral Artery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220021	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6.0 mm Stent Graft Proximal Diameter
Device Size Text, specify: 6.0 mm Stent Graft Distal Diameter
Device Size Text, specify: 135cm Catheter Working Length
Device Size Text, specify: 8F Delivery System Outer Profile
Device Size Text, specify: 100 mm Covered Stent Graft Length

Device Record Status

Public Device Record Key: 590d5d8a-4e43-4897-a0b4-3dab7b647f7a
Public Version Date: November 25, 2024
Public Version Number: 2
DI Record Publish Date: August 31, 2023