CraniSeal Dural Sealant CS-2015

GUDID 00860010683712

The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.

Pramand LLC

Dura mater sealant

• Primary Device ID: 00860010683712
• NIH Device Record Key: fc4212d9-12f7-4b2f-960c-7cab3d5c9d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CraniSeal Dural Sealant
• Version Model Number: CS-2015
• Catalog Number: CS-2015
• Company DUNS: 117587283
• Company Name: Pramand LLC
• Device Count: 5
• 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: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com
• Phone: 781-222-0081
• Email: regulatory@pramandllc.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010683705 [Primary]
GS1	00860010683712 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220014

FDA Product Code

• NQR: Sealant, Dural

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15