Regulus Introducer Set with Hemostatic Valve SYM-IS-003

GUDID 07640168110215

Introducer Set with Hemostatic Valve 6.3 mm

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 07640168110215
• NIH Device Record Key: 8ac53443-1e65-4388-91d3-fa5e8420063d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regulus Introducer Set with Hemostatic Valve
• Version Model Number: SYM-IS-003
• Catalog Number: SYM-IS-003
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com
• Phone: 727-937-2511
• Email: sales@oscor.com

Device Dimensions

• Lumen/Inner Diameter: 6.3 Millimeter
• Lumen/Inner Diameter: 6.3 Millimeter
• Lumen/Inner Diameter: 6.3 Millimeter
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6.3 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640168110215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140917

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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-11-30

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• 00885672012496 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F
• 00885672012502 - Baylis Med Tech Passport Steerable Sheath: 2023-03-23 Passport Steerable Sheath 6.5F