Ballast 02-8000-095

GUDID 10889981149314

Ballast, 45x17.5mm

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived

• Primary Device ID: 10889981149314
• NIH Device Record Key: 8b1038c7-6cf4-41cc-8b6d-419e07b1108b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ballast
• Version Model Number: 02-8000-095
• Catalog Number: 02-8000-095
• Company DUNS: 801089152
• Company Name: ISOTIS ORTHOBIOLOGICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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@seaspin
• Phone: +1(800)550-7155
• Email: irvine.customerservice@seaspin

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981149314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172130

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-05

On-Brand Devices [Ballast]

• 10889981149338: Ballast, 85x17.5mm
• 10889981149321: Ballast, 85x11mm
• 10889981149314: Ballast, 45x17.5mm
• 10889981149307: Ballast, 45x11mm
• 10889981232139: Ballast®, 150x11mm, 2-pack
• 10889981232122: Ballast®, 150x11mm, 1-pack