Destino Twist Steerable Guiding Sheath DCT1207139

GUDID 00885672006860

Steerable Guiding Sheath, 12F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672006860
• NIH Device Record Key: 212e0e35-b0ba-4b9f-b25a-1ade23042954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Destino Twist Steerable Guiding Sheath
• Version Model Number: DCT1207139
• Catalog Number: DCT1207139
• 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: 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
• 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
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5.3 Millimeter
• 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	00885672006860 [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

On-Brand Devices [Destino Twist Steerable Guiding Sheath]

• 00885672008819: Steerable Guiding Sheath, 13.5F
• 00885672008598: Steerable Guiding Sheath, 13.5F
• 00885672007836: Steerable Guiding Sheath, 7F
• 00885672007683: Steerable Guiding Sheath, 12F
• 00885672007676: Steerable Guiding Sheath, 12F
• 00885672007423: Steerable Guiding Sheath, 12F
• 00885672007218: Steerable Guiding Sheath, 12F
• 00885672007096: Steerable Guiding Sheath, 7F
• 00885672007089: Steerable Guiding Sheath, 12F
• 00885672007072: Steerable Guiding Sheath, 12F
• 00885672007065: Steerable Guiding Sheath, 12F
• 00885672007010: Steerable Guiding Sheath, 8.5F
• 00885672006952: Steerable Guiding Sheath, 13.8F
• 00885672006884: Steerable Guiding Sheath, 12F
• 00885672006877: Steerable Guiding Sheath, 12F
• 00885672006860: Steerable Guiding Sheath, 12F
• 00885672006853: Steerable Guiding Sheath, 12F
• 00885672006846: Steerable Guiding Sheath, 12F
• 00885672006839: Steerable Guiding Sheath, 12F
• 00885672006822: Steerable Guiding Sheath, 12F
• 00885672006716: Steerable Guiding Sheath, 12F
• 00885672006570: Steerable Guiding Sheath, 8.5F
• 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
• 00885672006471: Steerable Guiding Sheath, 12F
• 00885672006402: Steerable Guiding Sheath, 12F
• 00885672006181: Steerable Guiding Sheath, 7F
• 00885672005696: Steerable Guiding Sheath, 6.5F
• 00885672005689: Steerable Guiding Sheath, 6.5F
• 00885672005627: Steerable Guiding Sheath, 6.5F
• 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