Adelante Radial ASR04007B5

GUDID 10885672000575

Introducer Set with Hemostatic Valve, 4F

Oscor Inc.

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• Primary Device ID: 10885672000575
• NIH Device Record Key: 7078cf0d-1088-4ce5-a4ac-98a38a78d9a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante Radial
• Version Model Number: ASR04007B5
• Catalog Number: ASR04007B5
• 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

• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 Millimeter
• Needle Gauge: 21 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 45 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 1.5 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	00885672000578 [Unit of Use]
GS1	10885672000575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130633

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 Radial]

• 20885672004327: Introducer Set with Hemostatic Valve, 6F
• 20885672004310: Introducer Set with Hemostatic Valve, 5F
• 20885672004303: Introducer Set with Hemostatic Valve, 4F
• 20885672003894: Introducer Set with Hemostatic Valve, 6F
• 20885672003887: Introducer Set with Hemostatic Valve, 5F
• 20885672003870: Introducer Set with Hemostatic Valve, 4F
• 20885672000503: Introducer Set with Hemostatic Valve, 6F
• 20885672000497: Introducer Set with Hemostatic Valve, 5F
• 20885672000480: Introducer Set with Hemostatic Valve, 4F
• 10885672103726: Introducer Set with Hemostatic Valve, 5F
• 10885672103719: Introducer Set with Hemostatic Valve, 4F
• 10885672103665: Introducer Set with Hemostatic Valve, 6F
• 10885672006904: Introducer Set with Hemostatic Valve, 6F
• 10885672006898: Introducer Set with Hemostatic Valve, 5F
• 10885672003866: Introducer Set with Hemostatic Valve, 6F
• 10885672003859: Introducer Set with Hemostatic Valve, 5F
• 10885672003842: Introducer Set with Hemostatic Valve, 4F
• 10885672003835: Introducer Set with Hemostatic Valve, 6F
• 10885672003828: Introducer Set with Hemostatic Valve, 5F
• 10885672003811: Introducer Set with Hemostatic Valve, 4F
• 10885672003743: Introducer Set with Hemostatic Valve, 6F
• 10885672003736: Introducer Set with Hemostatic Valve, 5F
• 10885672003729: Introducer Set with Hemostatic Valve, 4F
• 10885672002197: Introducer Set with Hemostatic Valve, 6F
• 10885672002180: Introducer Set with Hemostatic Valve, 5F
• 10885672002173: Introducer Set with Hemostatic Valve, 4F
• 10885672002166: Introducer Set with Hemostatic Valve, 6F
• 10885672002159: Introducer Set with Hemostatic Valve, 5F
• 10885672002142: Introducer Set with Hemostatic Valve, 4F
• 10885672000636: Introducer Set with Hemostatic Valve, 6F
• 10885672000629: Introducer Set with Hemostatic Valve, 5F
• 10885672000612: Introducer Set with Hemostatic Valve, 4F
• 10885672000599: Introducer Set with Hemostatic Valve, 6F
• 10885672000582: Introducer Set with Hemostatic Valve, 5F
• 10885672000575: Introducer Set with Hemostatic Valve, 4F