Solum IV Bone Void Filler 1201-0020

GUDID 00817771028733

Celling Biosciences

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 00817771028733
• NIH Device Record Key: d9e01187-03f7-4fe4-a02d-aa476b704fad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solum IV Bone Void Filler
• Version Model Number: Solum IV - 2cc
• Catalog Number: 1201-0020
• 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	00817771028733 [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