Extended Tip Applicator 201108

GUDID 10381780000167

Extended Tip Applicator 8cm single pack

Integra Lifesciences Corporation

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 10381780000167
• NIH Device Record Key: 47362916-a016-43c0-a655-a1819137f761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extended Tip Applicator
• Version Model Number: 201108
• Catalog Number: 201108
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780000167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091315

FDA Product Code

• FMF: Syringe, Piston

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: 2020-07-16
• Device Publish Date: 2015-06-05

On-Brand Devices [Extended Tip Applicator]

• 10381780000167: Extended Tip Applicator 8cm single pack
• 10381780000150: Extended Tip Applicator 15cm 5 pack
• 30381780000147: Extended Tip Applicator 8cm 5 pack