Destino Reach Steerable Guiding Sheath DCR0856750GW

GUDID 00885672008017

Steerable Guiding Sheath, 8.5F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672008017
• NIH Device Record Key: 0ccc7399-dbe1-4da1-8668-bd5785714d02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Destino Reach Steerable Guiding Sheath
• Version Model Number: DCR0856750GW
• Catalog Number: DCR0856750GW
• 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
• 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
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• 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
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• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• 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
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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
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• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

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
• 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	00885672008017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151951

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 Reach Steerable Guiding Sheath]

• 00885672008178: Steerable Guiding Sheath, 12F
• 00885672008161: Steerable Guiding Sheath, 12F
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• 00885672008147: Steerable Guiding Sheath, 10F
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• 00885672008123: Steerable Guiding Sheath, 10F
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• 00885672008109: Steerable Guiding Sheath, 10F
• 00885672008093: Steerable Guiding Sheath, 10F
• 00885672008086: Steerable Guiding Sheath, 10F
• 00885672008079: Steerable Guiding Sheath, 8.5F
• 00885672008062: Steerable Guiding Sheath, 8.5F
• 00885672008055: Steerable Guiding Sheath, 8.5F
• 00885672008048: Steerable Guiding Sheath, 8.5F
• 00885672008031: Steerable Guiding Sheath, 8.5F
• 00885672008024: Steerable Guiding Sheath, 8.5F
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• 00885672008000: Steerable Guiding Sheath, 8.5F
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• 00885672007669: Steerable Guiding Sheath, 10F
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• 00885672007645: Steerable Guiding Sheath, 10F
• 00885672007638: Steerable Guiding Sheath, 10F
• 00885672007621: Steerable Guiding Sheath, 10F
• 00885672007614: Steerable Guiding Sheath, 8.5F
• 00885672007607: Steerable Guiding Sheath, 8.5F
• 00885672007591: Steerable Guiding Sheath, 8.5F
• 00885672007584: Steerable Guiding Sheath, 8.5F
• 00885672007577: Steerable Guiding Sheath, 8.5F
• 00885672007560: Steerable Guiding Sheath, 8.5F
• 00885672007553: Steerable Guiding Sheath, 8.5F
• 00885672007454: Steerable Guiding Sheath, 12F
• 00885672007447: Steerable Guiding Sheath, 12F
• 00885672007430: Steerable Guiding Sheath, 12F
• 00885672007256: Steerable Guiding Sheath, 12F
• 00885672007249: Steerable Guiding Sheath, 10F
• 00885672007232: Steerable Guiding Sheath, 8.5F
• 00885672007225: Steerable Guiding Sheath, 8.5F