GORE INTERING Vascular Graft IRST07080080L

GUDID H373IRST07080080L35

INTERING STR T7MM 80CM RS X 80

W. L. Gore & Associates, Inc.

Synthetic vascular graft

• Primary Device ID: H373IRST07080080L35
• NIH Device Record Key: 813a78f0-6948-4cb5-812b-3aa45ae11351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE INTERING Vascular Graft
• Version Model Number: IRST07080080L
• Catalog Number: IRST07080080L
• 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
• 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
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132607273 [Primary]
HIBCC	H373IRST07080080L35 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991602

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 INTERING Vascular Graft]

• H373IRST08080080L36: INTERING STR T8MM 80CM RS X 80
• H373IRST08060060L32: INTERING STR T8MM 60CM RS X 60
• H373IRST08040040L3: INTERING STR T8MM 40CM RS X 40
• H373IRST07080080L35: INTERING STR T7MM 80CM RS X 80
• H373IRST07060060L31: INTERING STR T7MM 60CM RS X 60
• H373IRST07040040L3: INTERING STR T7MM 40CM RS X 40
• H373IRST06080080L34: INTERING STR T6MM 80CM RS X 80
• H373IRST06060060L30: INTERING STR T6MM 60CM RS X 60
• H373IRST06040040L3: INTERING STR T6MM 40CM RS X 40
• H373IRST06005005L3: INTERING STR T6MM 5CM RS X 5
• 00733132607204: INTERING STR 4-7MM 38CM RSX 45
• 00733132607198: INTERING STR 4-6MM 38CM RSX 45
• H373IRS06040L36: INTERING STR 6MM 40CM RS X 40
• H373IRS06010020L35: INTERING STRETCH 6MM 10CMX20CM
• 00733132607167: INTERING STRETCH 6MM 5CM X45CM
• H373IRS06005020L39: INTERING STRETCH 6MM 5CM X20CM
• 00733132607020: INTERING 6MM 5CM X 45CM