Solum IV Bone Void Filler 1201-0100

GUDID 00817771028757

Celling Biosciences

Synthetic bone graft

• Primary Device ID: 00817771028757
• NIH Device Record Key: 94600e00-20ef-478c-9015-3ec65511a238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solum IV Bone Void Filler
• Version Model Number: Solum IV - 10cc
• Catalog Number: 1201-0100
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771028757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132470

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Solum IV Bone Void Filler]

• 00817771028764: Solum IV - 20cc
• 00817771028757: Solum IV - 10cc
• 00817771028740: Solum IV - 5cc
• 00817771028733: Solum IV - 2cc
• 00817771028726: Solum IV - 1cc