GORE-TEX Vascular Graft RR06030040L

GUDID H373RR06030040L3X

REM RG 6MM 30CM RS X 40CM

W. L. Gore & Associates, Inc.

Synthetic vascular graft

• Primary Device ID: H373RR06030040L3X
• NIH Device Record Key: d1eaf395-ee9b-4af5-ae2b-10f94c55e8c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE-TEX Vascular Graft
• Version Model Number: RR06030040L
• Catalog Number: RR06030040L
• 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

• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 40 Centimeter
• Lumen/Inner Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132610778 [Primary]
HIBCC	H373RR06030040L3X [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880167

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: 2017-01-10

On-Brand Devices [GORE-TEX Vascular Graft]

• H373RT04005015L3: RG T4MM 5CM RS X 15CM
• 00733132616275: VG 4MM X 40CM LINED
• H373VT68080L35: VG THINWALL 6-8MM X 80CM LINED
• H373VT45070L3: VG TW4.5-6.5MM X 70CM LINED
• 00733132616046: VG THIN WALL 8MM X 100CM LINED
• H373VT08080L3: VG THIN WALL 8MM X 80CM LINED
• H373VT08070L3: VG THIN WALL 8MM X 70CM LINED
• H373VT08040L3: VG THIN WALL 8MM X 40CM LINED
• H373VT07080L3: VG THIN WALL 7MM X 80CM LINED
• H373VT07070L3: VG THIN WALL 7MM X 70CM LINED
• H373VT07040L3: VG THIN WALL 7MM X 40CM LINED
• 00733132615971: VG THIN WALL 7MM X 10CM LINED
• 00733132615964: VG THIN WALL 6MM X 100CM LINED
• H373VT06080L3: VG THIN WALL 6MM X 80CM LINED
• H373VT06070L3: VG THIN WALL 6MM X 70CM LINED
• H373VT06050L3: VG THIN WALL 6MM X 50CM LINED
• H373VT06040L3: VG THIN WALL 6MM X 40CM LINED
• 00733132615919: VG THIN WALL 6MM X 10CM LINED
• 00733132615902: VG THIN WALL 5MM X 40CM LINED
• H373VT04080L3: VG THIN WALL 4MM X 80CM LINED
• H373VT04070L3: VG THIN WALL 4MM X 70CM LINED
• 00733132614257: VG 6-8MM X 80CM LINED
• 00733132614240: VG 6-8MM X 70CM LINED
• 00733132614233: VG 4-7MM X 50CM LINED
• 00733132614226: VG 4-7MM X 40CM LINED
• 00733132614219: VG 4-7MM X 30CM LINED
• 00733132614202: VG 4-6MM X 50CM LINED
• 00733132614196: VG 4-6MM X 40CM LINED
• 00733132614189: VG 4.5-6.5MM X 70CM LINED
• H373V10080L36: VG 10MM X 80CM LINED
• H373V08100L36: VG 8MM X 100CM LINED
• 00733132614158: VG 8MM X 90CM LINED
• 00733132614141: VG 8MM X 80CM LINED
• 00733132614134: VG 8MM X 70CM LINED
• 00733132614127: VG 8MM X 50CM LINED
• H373V08040L39: VG 8MM X 40CM LINED
• 00733132614103: VG 7MM X 80CM LINED
• 00733132614097: VG 7MM X 70CM LINED
• H373V07040L38: VG 7MM X 40CM LINED
• H373V06100L34: VG 6MM X 100CM LINED
• 00733132614066: VG 6MM X 90CM LINED
• 00733132614059: VG 6MM X 80CM LINED
• 00733132614042: VG 6MM X 70CM LINED
• H373V06050L38: VG 6MM X 50CM LINED
• H373V06040L37: VG 6MM X 40CM LINED
• H373V06030L36: VG 6MM X 30CM LINED
• H373V06020L35: VG 6MM X 20CM LINED
• H373V06010L34: VG 6MM X 10CM LINED
• H373V05070L39: VG 5MM X 70CM LINED
• H373V05040L36: VG 5MM X 40CM LINED