IsoTis Mozaik™ PTY10125ITL

GUDID 10889981123260

IsoTis Mozaik™ Putty, 2.5cc

SEASPINE ORTHOPEDICS CORPORATION

Bone matrix implant, composite

• Primary Device ID: 10889981123260
• NIH Device Record Key: c9c4ec5d-213f-4914-881e-07ad2a53e77f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoTis Mozaik™
• Version Model Number: PTY10125ITL
• Catalog Number: PTY10125ITL
• 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	10889981123260 [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 [IsoTis Mozaik™]

• 10889981123314: IsoTis Mozaik™ Strip, 15cc
• 10889981123307: IsoTis Mozaik™ Strip, 10cc
• 10889981123291: IsoTis Mozaik™ Putty, 15cc
• 10889981123284: IsoTis Mozaik™ Putty, 10cc
• 10889981123277: IsoTis Mozaik™ Putty, 5cc
• 10889981123260: IsoTis Mozaik™ Putty, 2.5cc