GORE-TEX Stretch Vascular Graft SAX02D

GUDID 00733132611782

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

W. L. Gore & Associates, Inc.

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