GORE Molding Occlusion Balloon Catheter MOB37

GUDID 00733132639489

MOB 10-37mm x 4.0cm x 90cm

W. L. Gore & Associates, Inc.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00733132639489
• NIH Device Record Key: 4f829ae6-9843-4828-84f9-6ee9b866d7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE Molding Occlusion Balloon Catheter
• Version Model Number: MOB37
• Catalog Number: MOB37
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com
• Phone: 8005288763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132639489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172567

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-08-13

Devices Manufactured by W. L. Gore & Associates, Inc.

• 00733132619832 - GORE® Tri-Lobe Balloon Catheter: 2025-06-19 TRI-LOBE BALLOON CATHETER 18Fr
• 00733132619849 - GORE® Tri-Lobe Balloon Catheter: 2025-06-19 TRI-LOBE BALLOON CATHETER 18Fr
• 00733132661664 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 34MMX28MMX15CM 22Fr
• 00733132661671 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 45MMX37MMX15CM 24Fr
• 00733132661688 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 37MMX31MMX15CM 22Fr
• 00733132661695 - GORE TAG Conformable Thoracic Stent Graft: 2025-03-26 CTAG CMDS 40MMX34MMX15CM 22Fr
• 00733132658855 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx10Fr
• 00733132658862 - GORE® DrySeal Flex Introducer Sheath: 2024-12-10 DrySeal Hydro Flex Sheath PI 45cmx10Fr