DuraSeal Exact Spinal Sealant System 206520

GUDID 30381780000048

DuraSeal Exact Spinal Sealant System 5mL 5 pack

Integra Lifesciences Corporation

Dura mater sealant

• Primary Device ID: 30381780000048
• NIH Device Record Key: 51edd732-3773-48e4-a9cb-03391926a4aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraSeal Exact Spinal Sealant System
• Version Model Number: 206520
• Catalog Number: 206520
• 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: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 800-654-2873
• Email: custsvcnj@integralife.com
• Phone: 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
• 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

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Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780000044 [Primary]
GS1	30381780000048 [Package]; Contains: 10381780000044; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080013

FDA Product Code

• NQR: Sealant, Dural

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: 2019-10-23
• Device Publish Date: 2016-12-29

On-Brand Devices [DuraSeal Exact Spinal Sealant System]

• 30381780000048: DuraSeal Exact Spinal Sealant System 5mL 5 pack
• 30381780000031: DuraSeal Exact Spinal Sealant System 3mL 5 pack