GORE-TEX Stretch Vascular Graft SAX02D

GUDID 00733132611782

SRR 8MM X 90CM/8MM X 40CM

W. L. Gore & Associates, Inc.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 00733132611782
• NIH Device Record Key: f27983a1-d6c9-4ef6-ac63-80c3f2449c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Stretch Vascular Graft
• Version Model Number: SAX02D
• Catalog Number: SAX02D
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter
• Length: 75 Centimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132611782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901641

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-28
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE-TEX Stretch Vascular Graft]

• 00733132611782: SRR 8MM X 90CM/8MM X 40CM
• 00733132611768: SRR 8MM X 70CM/8MM X 40CM
• H373SA24043: STRETCH 24MM X 40CM
• H373SA24033Z: STRETCH 24MM X 30CM
• H373SA24023Y: STRETCH 24MM X 20CM
• H373SA22043Y: STRETCH 22MM X 40CM
• H373SA22033X: STRETCH 22MM X 30CM
• H373SA22023W: STRETCH 22MM X 20CM
• H373SA20043W: STRETCH 20MM X 40CM
• H373SA20033V: STRETCH 20MM X 30CM
• H373SA20023U: STRETCH 20MM X 20CM
• H373SA18043: STRETCH 18MM X 40CM
• H373SA18033: STRETCH 18MM X 30CM
• H373SA18023: STRETCH 18MM X 20CM
• H373SA16043: STRETCH 16MM X 40CM
• H373SA16033: STRETCH 16MM X 30CM
• H373SA16023Z: STRETCH 16MM X 20CM
• H373SA14043Z: STRETCH 14MM X 40CM
• H373SA14033Y: STRETCH 14MM X 30CM
• H373SA14023X: STRETCH 14MM X 20CM
• 00733132611560: S 4-7MM X 70CM
• H373S470553: S 4-7MM X 55CM
• H373S470483: S 4-7MM X 48CM
• H373S470453: S 4-7MM X 45CM
• 00733132611522: S 4-7MM X 40CM
• 00733132611515: S 4-7MM X 30CM
• H373S460483: S 4-6MM X 48CM
• 00733132611492: S 4-6MM X 45CM
• H373S12043N: STRETCH 12MM X 40CM
• H373S12033M: STRETCH 12MM X 30CM
• H373S12023L: STRETCH 12MM X 20CM
• H373S10083P: STRETCH 10MM X 80CM
• H373S10043L: STRETCH 10MM X 40CM
• H373S08093X: STRETCH 8MM X 90CM
• H373S08083W: STRETCH 8MM X 80CM
• H373S08073V: STRETCH 8MM X 70CM
• H373S08053T: STRETCH 8MM X 50CM
• H373S08043S: STRETCH 8MM X 40CM
• H373S08013P: STRETCH 8MM X 10CM
• H373S07083V: STRETCH 7MM X 80CM
• H373S07073U: STRETCH 7MM X 70CM
• H373S07043R: STRETCH 7MM X 40CM
• H373S07013O: STRETCH 7MM X 10CM
• H373S06093V: STRETCH 6MM X 90CM
• H373S06083U: STRETCH 6MM X 80CM
• H373S06073T: STRETCH 6MM X 70CM
• H373S06053R: STRETCH 6MM X 50CM
• H373S06043Q: STRETCH 6MM X 40CM
• H373S06033P: STRETCH 6MM X 30CM
• H373S06023O: STRETCH 6MM X 20CM