Current 02-9000-050

GUDID 10889981180485

Current, 5cc

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, composite

• Primary Device ID: 10889981180485
• NIH Device Record Key: 7efd6d35-a8cc-41e4-b5c8-d4a9b7918185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Current
• Version Model Number: 02-9000-050
• Catalog Number: 02-9000-050
• Company DUNS: 801089152
• Company Name: ISOTIS ORTHOBIOLOGICS, INC.
• Device Count: 1
• DM Exempt: true
• 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)550-7155
• Email: customerservice@seaspine.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981180485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181958

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: 2019-11-05
• Device Publish Date: 2019-10-28

On-Brand Devices [Current]

• 10889981180492: Current, 10cc
• 10889981180485: Current, 5cc
• 10889981180478: Current, 2.5cc
• 10889981180461: Current, 1cc