GORE Molding Occlusion Balloon Catheter

Basic Information

• Brand Name: GORE Molding Occlusion Balloon Catheter
• Primary DI: 00733132639489
• Version / Model: MOB37
• Catalog Number: MOB37
• Company Name: W. L. Gore & Associates, Inc.
• Labeler DUNS: 967358115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-13
• Public Version: 5
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: 4f829ae6-9843-4828-84f9-6ee9b866d7ea

Device Description

MOLDING OCCLUSION BALLOON CATH 10mm - 37mm 10Fr

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66383	Intravascular occluding/stent-graft post-dilation balloon catheter	A dual-purpose flexible tube or shaft with an inflatable balloon at its distal end intended for short-term (<= 30 days) percutaneous introduction, under image guidance, to: 1) temporarily block a large blood vessel (e.g., aorta, iliac artery), typically for emergency control of haemorrhage; and 2) dilate a previously deployed stent-graft (not included) for stabilization in the vessel. Disposable devices intended for catheter introduction may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733132639489	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172567	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Effective Length: 90 cm
Catheter Gauge	10	French
Device Size Text, specify			Maximum Balloon Diameter: 10-37 mm