OsteoStrux® 56070100ITL

GUDID 10889981123345

OsteoStrux® Putty, 10cc

SEASPINE ORTHOPEDICS CORPORATION

Bone matrix implant, composite

• Primary Device ID: 10889981123345
• NIH Device Record Key: 69c445ae-1347-40e3-b207-becc41cf2e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoStrux®
• Version Model Number: 56070100ITL
• Catalog Number: 56070100ITL
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS 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: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.com
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspine.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981123345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062353

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

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: 2020-10-27
• Device Publish Date: 2020-10-19

On-Brand Devices [OsteoStrux®]

• 10889981123376: OsteoStrux® Strip, 15cc
• 10889981123369: OsteoStrux® Strip, 10cc
• 10889981123352: OsteoStrux® Putty, 15cc
• 10889981123345: OsteoStrux® Putty, 10cc
• 10889981123338: OsteoStrux® Putty, 5cc
• 10889981123321: OsteoStrux® Putty, 2.5cc