Duraseal 206320

GUDID 20884521056371

Exact Spine Sealant System,

Covidien LP

Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant Dura mater sealant

• Primary Device ID: 20884521056371
• NIH Device Record Key: f466f8ea-03dd-4fdf-9127-b7cc180d1029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duraseal
• Version Model Number: 206320
• Catalog Number: 206320
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• 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
• 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
• 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
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage 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	10884521056374 [Package]; Package: CASE [5 Units]; In Commercial Distribution
GS1	20884521056371 [Primary]

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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2014-09-22

On-Brand Devices [Duraseal]

• 20884521056432: Dural Sealant System,
• 20884521056388: Exact Spine Sealant System,
• 20884521056371: Exact Spine Sealant System,
• 10884521056411: Dural Sealant System,