Adelante Sigma

GUDID 00836559007050

Introducer Set with Hemostatic Valve, 11F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00836559007050
• NIH Device Record Key: 99cd8447-9233-4614-bce0-f5ac76244aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante Sigma
• Version Model Number: ASGAT11016
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 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
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.8 Millimeter
• Device Size Text, specify: 0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559007050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090114

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: 2017-12-07

On-Brand Devices [Adelante Sigma]

• 00885672008772: Introducer Set with Hemostatic Valve, 6F
• 20885672101446: Introducer Set with Hemostatic Valve, 12F
• 20885672101439: Introducer Set with Hemostatic Valve, 11F
• 20885672101422: Introducer Set with Hemostatic Valve, 10F
• 20885672101415: Introducer Set with Hemostatic Valve, 9F
• 20885672101408: Introducer Set with Hemostatic Valve, 8F
• 20885672101392: Introducer Set with Hemostatic Valve, 7F
• 20885672101385: Introducer Set with Hemostatic Valve, 6F
• 20885672101378: Introducer Set with Hemostatic Valve, 5F
• 20885672101361: Introducer Set with Hemostatic Valve, 4F
• 20885672101354: Introducer Set with Hemostatic Valve, 12F
• 20885672101347: Introducer Set with Hemostatic Valve, 11F
• 20885672101330: Introducer Set with Hemostatic Valve, 10F
• 20885672101323: Introducer Set with Hemostatic Valve, 9F
• 20885672101316: Introducer Set with Hemostatic Valve, 8F
• 20885672101309: Introducer Set with Hemostatic Valve, 7F
• 20885672101293: Introducer Set with Hemostatic Valve, 6F
• 20885672101286: Introducer Set with Hemostatic Valve, 5F
• 20885672101279: Introducer Set with Hemostatic Valve, 4F
• 10885672101050: Hemostatic Valve Introducer, 12F
• 10885672101036: Hemostatic Valve Introducer, 11F
• 10885672101012: Hemostatic Valve Introducer, 10F
• 10885672100992: Hemostatic Valve Introducer, 9F
• 10885672100978: Hemostatic Valve Introducer, 8F
• 10885672100954: Hemostatic Valve Introducer, 7F
• 10885672100923: Hemostatic Valve Introducer, 4F
• 10836559009464: Hemostatic Valve Introducer, 12F
• 10836559009457: Hemostatic Valve Introducer, 11F
• 10836559009440: Hemostatic Valve Introducer, 10F
• 10836559009433: Hemostatic Valve Introducer, 9F
• 10836559007415: Hemostatic Valve Introducer, 8F
• 10836559007408: Hemostatic Valve Introducer, 7F
• 10836559007378: Hemostatic Valve Introducer, 4F
• 10885672100947: Introducer Set with Hemostatic Valve, 6F
• 10885672100930: Introducer Set with Hemostatic Valve, 5F
• 10885672009233: Hemostatic Valve Introducer, 6F
• 10885672009226: Hemostatic Valve Introducer, 5F
• 10885672009219: Hemostatic Valve Introducer, 6F
• 10885672009202: Hemostatic Valve Introducer, 5F
• 10885672009134: Hemostatic Valve Introducer, 12F
• 10885672009127: Hemostatic Valve Introducer, 11F
• 10885672009110: Hemostatic Valve Introducer, 10F
• 10885672009103: Hemostatic Valve Introducer, 9F
• 10885672009097: Hemostatic Valve Introducer, 8F
• 10885672009080: Hemostatic Valve Introducer, 7F
• 10885672009073: Hemostatic Valve Introducer, 6F
• 10885672009066: Hemostatic Valve Introducer, 5F
• 10885672009059: Hemostatic Valve Introducer, 4F
• 10885672009042: Hemostatic Valve Introducer, 12F
• 10885672009035: Hemostatic Valve Introducer, 11F