Destino Twist HTS Steerable Guiding Sheath DSTS1205520

GUDID 00885672011239

Steerable Guiding Sheath, 12F

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: 00885672011239
• NIH Device Record Key: 45b101ce-7606-49e5-bc7e-1724a954bc81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Destino Twist HTS Steerable Guiding Sheath
• Version Model Number: DSTS1205520
• Catalog Number: DSTS1205520
• 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

• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 5.4 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672011239 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-26
• Device Publish Date: 2021-10-18

On-Brand Devices [Destino Twist HTS Steerable Guiding Sheath]

• 00885672011246: Steerable Guiding Sheath, 12F
• 00885672011239: Steerable Guiding Sheath, 12F