Sleek OTW PTA Dilatation Catheter 426-4002X

GUDID 00801741133886

Sleek OTW PTA Dilatation Catheter 4.0mm x 20mm balloon, 150cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00801741133886
• NIH Device Record Key: d720243c-5376-475c-a9dd-85335fdb17a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleek OTW PTA Dilatation Catheter
• Version Model Number: 426-4002X
• Catalog Number: 426-4002X
• 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	00801741133886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130786

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

On-Brand Devices [Sleek OTW PTA Dilatation Catheter]

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• 00801741133893: Sleek OTW PTA Dilatation Catheter 4.0mm x 40mm balloon, 150cm shaft
• 00801741133886: Sleek OTW PTA Dilatation Catheter 4.0mm x 20mm balloon, 150cm shaft
• 00801741133879: Sleek OTW PTA Dilatation Catheter 3.5mm x 280mm balloon, 150cm shaft
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• 00801741133824: Sleek OTW PTA Dilatation Catheter 3.5mm x 80mm balloon, 150cm shaft
• 00801741133817: Sleek OTW PTA Dilatation Catheter 3.5mm x 40mm balloon, 150cm shaft
• 00801741133800: Sleek OTW PTA Dilatation Catheter 3.5mm x 20mm balloon, 150cm shaft
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• 00801741133770: Sleek OTW PTA Dilatation Catheter 3.0mm x 150mm balloon, 150cm shaft
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• 00801741133756: Sleek OTW PTA Dilatation Catheter 3.0mm x 100mm balloon, 150cm shaft
• 00801741133749: Sleek OTW PTA Dilatation Catheter 3.0mm x 80mm balloon, 150cm shaft
• 00801741133732: Sleek OTW PTA Dilatation Catheter 3.0mm x 40mm balloon, 150cm shaft
• 00801741133725: Sleek OTW PTA Dilatation Catheter 3.0mm x 20mm balloon, 150cm shaft
• 00801741133718: Sleek OTW PTA Dilatation Catheter 2.5mm x 280mm balloon, 150cm shaft
• 00801741133701: Sleek OTW PTA Dilatation Catheter 2.5mm x 220mm balloon, 150cm shaft
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• 00801741133657: Sleek OTW PTA Dilatation Catheter 2.5mm x 40mm balloon, 150cm shaft
• 00801741133640: Sleek OTW PTA Dilatation Catheter 2.5mm x 20mm balloon, 150cm shaft
• 00801741133633: Sleek OTW PTA Dilatation Catheter 2.0mm x 280mm balloon, 150cm shaft
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