Adelante Peel-Away Introducer Set AP08516P

GUDID 20885672101125

Peel-Away Introducer Set, 8.5F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20885672101125
• NIH Device Record Key: 801eb0cf-ba4e-4c0a-a1d1-0a85c96d0e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante Peel-Away Introducer Set
• Version Model Number: AP08516P
• Catalog Number: AP08516P
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 10
• 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

Device Dimensions

• Lumen/Inner Diameter: 2.8 Millimeter
• Lumen/Inner Diameter: 2.8 Millimeter
• Lumen/Inner Diameter: 2.8 Millimeter
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.8 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672101121 [Unit of Use]
GS1	20885672101125 [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: 2017-11-15

On-Brand Devices [Adelante Peel-Away Introducer Set]

• 20885672103556: Peel-Away Introducer Set, 9F
• 20885672101262: Peel-Away Introducer Set, 12F
• 20885672101255: Peel-Away Introducer Set, 11F
• 20885672101248: Peel-Away Introducer Set, 10F
• 20885672101231: Peel-Away Introducer Set, 9F
• 20885672101224: Peel-Away Introducer Set, 8F
• 20885672101217: Peel-Away Introducer Set, 7F
• 20885672101200: Peel-Away Introducer Set, 12.5F
• 20885672101194: Peel-Away Introducer Set, 12F
• 20885672101187: Peel-Away Introducer Set, 11.5F
• 20885672101170: Peel-Away Introducer Set, 11F
• 20885672101163: Peel-Away Introducer Set, 10.5F
• 20885672101156: Peel-Away Introducer Set, 10F
• 20885672101149: Peel-Away Introducer Set, 9.5F
• 20885672101132: Peel-Away Introducer Set, 9F
• 20885672101125: Peel-Away Introducer Set, 8.5F
• 20885672101118: Peel-Away Introducer Set, 8F
• 20885672101101: Peel-Away Introducer Set, 7.5F
• 20885672101095: Peel-Away Introducer Set, 7F
• 20885672101088: Peel-Away Introducer Set, 6F
• 20885672008820: Peel-Away Introducer Set, 6F
• 20885672002484: Peel-Away Introducer Set, 8F
• 20885672002460: Peel-Away Introducer Set, 7F
• 20885672002453: Peel-Away Introducer Set, 6F
• 20885672002132: Peel-Away Introducer Set, 12.5F
• 20885672002125: Peel-Away Introducer Set, 12F
• 20885672002118: Peel-Away Introducer Set, 11.5F
• 20885672002101: Peel-Away Introducer Set, 11F
• 20885672002095: Peel-Away Introducer Set, 10.5F
• 20885672002088: Peel-Away Introducer Set, 10F
• 20885672002071: Peel-Away Introducer Set, 9.5F
• 20885672002064: Peel-Away Introducer Set, 9F
• 20885672002057: Peel-Away Introducer Set, 8.5F
• 20885672002040: Peel-Away Introducer Set, 8F
• 20885672002033: Peel-Away Introducer Set, 7.5F
• 20885672002026: Peel-Away Introducer Set, 7F
• 20885672000060: Peel-Away Introducer Set, 6F
• 10885672100190: Peel-Away Introducer Set, 12F
• 10885672100183: Peel-Away Introducer Set, 11F
• 10885672100176: Peel-Away Introducer Set, 10F
• 10885672100169: Peel-Away Introducer Set, 9F
• 10885672100152: Peel-Away Introducer Set, 8F
• 10885672100145: Peel-Away Introducer Set, 7F
• 10885672100138: Peel-Away Introducer Set, 12.5F
• 10885672100121: Peel-Away Introducer Set, 12F
• 10885672100114: Peel-Away Introducer Set, 11.5F
• 10885672100107: Peel-Away Introducer Set, 11F
• 10885672100091: Peel-Away Introducer Set, 10.5F
• 10885672100084: Peel-Away Introducer Set, 10F
• 10885672100077: Peel-Away Introducer Set, 9.5F