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

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

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