Baylis Med Tech Passport Steerable Sheath PSS0655517

GUDID 00885672012526

Passport Steerable Sheath 6.5F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672012526
• NIH Device Record Key: 97e57651-1a99-417e-8409-cb75f9e655e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baylis Med Tech Passport Steerable Sheath
• Version Model Number: PSS0655517
• Catalog Number: PSS0655517
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 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: 2.2 Millimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672012526 [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: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [Baylis Med Tech Passport Steerable Sheath]

• 00885672012625: Passport Steerable Sheath 13.8F
• 00885672012618: Passport Steerable Sheath 12F
• 00885672012601: Passport Steerable Sheath 8.5F
• 00885672012595: Passport Steerable Sheath 7F TD Curve
• 00885672012588: Passport Steerable Sheath 7F
• 00885672012571: Passport Steerable Sheath 7F
• 00885672012564: Passport Steerable Sheath 7F
• 00885672012557: Passport Steerable Sheath 7F
• 00885672012540: Passport Steerable Sheath 7F
• 00885672012533: Passport Steerable Sheath 6.5F Dual Dilator
• 00885672012526: Passport Steerable Sheath 6.5F
• 00885672012519: Passport Steerable Sheath 6.5F
• 00885672012502: Passport Steerable Sheath 6.5F
• 00885672012496: Passport Steerable Sheath 6.5F
• 00885672012489: Passport Steerable Sheath 6.5F