Destino Twist Steerable Guiding Sheath DST0854517

GUDID 00885672006501

Steerable Guiding Sheath, 8.5F

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 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: 00885672006501
• NIH Device Record Key: 8e2a81a5-e2de-4e87-974b-6b147b6daff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Destino Twist Steerable Guiding Sheath
• Version Model Number: DST0854517
• Catalog Number: DST0854517
• 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: 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: +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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672006501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140406

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-11-27

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• 00885672007072: Steerable Guiding Sheath, 12F
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• 00885672006563: Steerable Guiding Sheath, 8.5F
• 00885672006556: Steerable Guiding Sheath, 8.5F
• 00885672006549: Steerable Guiding Sheath, 8.5F
• 00885672006532: Steerable Guiding Sheath, 8.5F
• 00885672006525: Steerable Guiding Sheath, 8.5F
• 00885672006518: Steerable Guiding Sheath, 8.5F
• 00885672006501: Steerable Guiding Sheath, 8.5F
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• 00885672005597: Steerable Guiding Sheath, 13.8F
• 00885672004422: Steerable Guiding Sheath, 7F
• 00885672004415: Steerable Guiding Sheath, 7F
• 00885672004408: Steerable Guiding Sheath, 7F
• 00885672004286: Steerable Guiding Sheath, 8.5F
• 00885672004279: Steerable Guiding Sheath, 8.5F
• 00885672004262: Steerable Guiding Sheath, 8.5F
• 00885672004255: Steerable Guiding Sheath, 8.5F
• 00885672004248: Steerable Guiding Sheath, 8.5F
• 00885672004224: Steerable Guiding Sheath, 8.5F
• 00885672004217: Steerable Guiding Sheath, 8.5F
• 00885672004200: Steerable Guiding Sheath, 7F
• 00885672004194: Steerable Guiding Sheath, 7F
• 00885672004187: Steerable Guiding Sheath, 7F
• 00885672004170: Steerable Guiding Sheath, 7F