Occlutech Delivery Set III 98DL010

GUDID 00885672010324

OCCLUTECH DELIVERY SET III, 10F 110CM 45°

Oscor Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00885672010324
• NIH Device Record Key: ea8eb225-a348-436f-b3e0-116927faa9e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Occlutech Delivery Set III
• Version Model Number: 98DL010
• Catalog Number: 98DL010
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 4.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210627

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Occlutech Delivery Set III]

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• 00885672010300: OCCLUTECH DELIVERY SET III, 10F 79CM 45°
• 00885672010294: OCCLUTECH DELIVERY SET III, 9F 110CM 45°
• 00885672010287: OCCLUTECH DELIVERY SET III, 9F 79CM 180°
• 00885672010270: OCCLUTECH DELIVERY SET III, 9F 79CM 45°
• 00885672010263: OCCLUTECH DELIVERY SET III, 8F 110CM 45°
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• 00885672010249: OCCLUTECH DELIVERY SET III, 8F 79CM 45°
• 00885672010232: OCCLUTECH DELIVERY SET III, 7F 110CM 45°
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• 00885672010218: OCCLUTECH DELIVERY SET III, 7F 79CM 45°
• 00885672010201: OCCLUTECH DELIVERY SET III, 6F 110CM 45°
• 00885672010195: OCCLUTECH DELIVERY SET III, 6F 79CM 180°
• 00885672010188: OCCLUTECH DELIVERY SET III, 6F 79CM 45°