DURAFORM NT801472US

GUDID 00382830048873

Dural Graft Implant 1”x 1” (2.54cm x 2.54cm)

NATUS MEDICAL INCORPORATED

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• Primary Device ID: 00382830048873
• NIH Device Record Key: 62b4d2f6-8f97-43d9-9134-19134ca5b33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAFORM
• Version Model Number: NT801472US
• Catalog Number: NT801472US
• Company DUNS: 081325959
• Company Name: NATUS MEDICAL INCORPORATED
• 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: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830048873 [Primary]
GS1	00382830056267 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152481

FDA Product Code

• GXQ: Dura Substitute

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: 2019-07-08
• Device Publish Date: 2019-06-28

On-Brand Devices [DURAFORM]

• 00382830048941: Dural Graft Implant 4”x 5” (10.16cm x 12.7cm)
• 00382830048927: Dural Graft Implant 3”x 3” (7.62cm x 7.62cm)
• 00382830048903: Dural Graft Implant 2”x 2” (5.08cm x 5.08cm)
• 00382830048880: Dural Graft Implant 1”x 3” (2.54cm x 7.62cm)
• 00382830048934: Dural Graft Implant 3”x 3” (7.62cm x 7.62cm)
• 00382830048910: Dural Graft Implant 2”x 2” (5.08cm x 5.08cm)
• 00382830048897: Dural Graft Implant 1”x 3” (2.54cm x 7.62cm)
• 00382830048873: Dural Graft Implant 1”x 1” (2.54cm x 2.54cm)