Savvy Long PTA Dilatation Catheter 436-2015X

GUDID 00801741132704

Savvy Long PTA Dilatation Catheter 2.0mm x 150mm balloon, 150cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

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• Primary Device ID: 00801741132704
• NIH Device Record Key: 986774c8-68f2-4a33-8514-6b8b96fbb3eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Savvy Long PTA Dilatation Catheter
• Version Model Number: 436-2015X
• Catalog Number: 436-2015X
• Company DUNS: 989214291
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741132704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072947

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

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: 2019-08-09
• Device Publish Date: 2016-09-16

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