Exact Spine Sealant System,

Exact Spine Sealant System,
Duraseal - 206520

An implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.

• Nominal inner volume content,5,Milliliter;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQR

Device Name: Sealant, Dural

Device Class: 3

Physical State: N/A

Definition: Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 20884521056388

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10884521056381

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521056388

Package Quantity: 5

Package Discontinue Date: 2/21/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE