Adelante S ASU01013B5

GUDID 10885672104563

Peel-Away Introducer with Hemostatic Valve and Side Port, 10F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10885672104563
• NIH Device Record Key: 4fb00229-a6de-4402-ae20-18e4547efa04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante S
• Version Model Number: ASU01013B5
• Catalog Number: ASU01013B5
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 5
• 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

Device Dimensions

• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Needle Gauge: 18 Gauge

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	00885672104566 [Unit of Use]
GS1	10885672104563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073100

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: 2017-11-16

On-Brand Devices [Adelante S]

• 10885672104686: Peel-Away Introducer with Hemostatic Valve and Side Port, 11F
• 10885672104679: Peel-Away Introducer with Hemostatic Valve and Side Port, 10F
• 10885672104662: Peel-Away Introducer with Hemostatic Valve and Side Port, 9F
• 10885672104655: Peel-Away Introducer with Hemostatic Valve and Side Port, 8F
• 10885672104648: Peel-Away Introducer with Hemostatic Valve and Side Port, 7F
• 10885672104631: Peel-Away Introducer with Hemostatic Valve and Side Port, 6F
• 10885672104624: Peel-Away Introducer with Hemostatic Valve and Side Port, 7.5F
• 10885672104617: Peel-Away Introducer with Hemostatic Valve and Side Port, 5F
• 10885672104600: Peel-Away Introducer with Hemostatic Valve and Side Port, 12.5F
• 10885672104594: Peel-Away Introducer with Hemostatic Valve and Side Port, 12F
• 10885672104587: Peel-Away Introducer with Hemostatic Valve and Side Port, 11F
• 10885672104570: Peel-Away Introducer with Hemostatic Valve and Side Port, 10.5F
• 10885672104563: Peel-Away Introducer with Hemostatic Valve and Side Port, 10F
• 10885672104556: Peel-Away Introducer with Hemostatic Valve and Side Port, 9.5F
• 10885672104549: Peel-Away Introducer with Hemostatic Valve and Side Port, 9F
• 10885672104532: Peel-Away Introducer with Hemostatic Valve and Side Port, 8.5F
• 10885672104525: Peel-Away Introducer with Hemostatic Valve and Side Port, 8F
• 10885672104518: Peel-Away Introducer with Hemostatic Valve and Side Port, 7F
• 10885672104501: Peel-Away Introducer with Hemostatic Valve and Side Port, 6F