Destino Steerable Guiding Sheath D0M122550

GUDID 00885672004538

Steerable Guiding Sheath, 12F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672004538
• NIH Device Record Key: 4f52cc39-cb5f-40e5-9f5b-7d0610ebeade
• Commercial Distribution Discontinuation: 2016-11-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Destino Steerable Guiding Sheath
• Version Model Number: D0M122550
• Catalog Number: D0M122550
• 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

• Lumen/Inner Diameter: 4.2 Millimeter
• Lumen/Inner Diameter: 4.2 Millimeter
• Lumen/Inner Diameter: 4.2 Millimeter
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.2 Millimeter

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	00885672004538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120459

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

[00885672004538]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-11-30

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• 00885672001018: Steerable Guiding Sheath, 12F
• 00885672001001: Steerable Guiding Sheath, 10F
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• 00885672000912: Steerable Guiding Sheath, 8.5F
• 00885672000905: Steerable Guiding Sheath, 8.5F
• 00885672000899: Steerable Guiding Sheath, 8.5F
• 00885672000882: Steerable Guiding Sheath, 8.5F
• 00885672000875: Steerable Guiding Sheath, 8.5F
• 00885672000868: Steerable Guiding Sheath, 8.5F
• 00885672000851: Steerable Guiding Sheath, 12F
• 00885672000844: Steerable Guiding Sheath, 12F
• 00885672000837: Steerable Guiding Sheath, 12F
• 00885672000820: Steerable Guiding Sheath, 12F
• 00885672000813: Steerable Guiding Sheath, 12F
• 00885672000806: Steerable Guiding Sheath, 12F
• 00885672000790: Steerable Guiding Sheath, 10F
• 00885672000783: Steerable Guiding Sheath, 10F
• 00885672000776: Steerable Guiding Sheath, 10F