Senovo Bi-Flex Steerable Guiding Sheath 454994

GUDID 00885672010003

Steerable Guiding Sheath, 8.5F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672010003
• NIH Device Record Key: 0aa5e8f0-7b22-4fcb-bd7a-a63d283c6ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senovo Bi-Flex Steerable Guiding Sheath
• Version Model Number: 454994
• Catalog Number: 454994
• 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
• 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
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 77 Centimeter
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010003 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-20
• Device Publish Date: 2020-08-12

On-Brand Devices [Senovo Bi-Flex Steerable Guiding Sheath]

• 00885672010003: Steerable Guiding Sheath, 8.5F
• 00885672009991: Steerable Guiding Sheath, 8.5F
• 00885672009984: Steerable Guiding Sheath, 8.5F
• 00885672009977: Steerable Guiding Sheath, 12F
• 00885672009960: Steerable Guiding Sheath, 12F
• 00885672009953: Steerable Guiding Sheath, 12F
• 00885672009946: Steerable Guiding Sheath, 12F
• 00885672009939: Steerable Guiding Sheath, 8.5F
• 00885672009922: Steerable Guiding Sheath, 8.5F
• 00885672009915: Steerable Guiding Sheath, 8.5F