Solum Flow 1206-0020

GUDID 00817771028801

Celling Biosciences

Synthetic bone graft

• Primary Device ID: 00817771028801
• NIH Device Record Key: c1dd8ccd-5b89-4b5c-97a5-279fa683592e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solum Flow
• Version Model Number: Solum Flow - 2cc
• Catalog Number: 1206-0020
• 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	00817771028801 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [Solum Flow]

• 00817371020632: Solum Flow - 5cc
• 00817371020625: Solum Flow - 2cc
• 00817771028818: Solum Flow - 5cc
• 00817771028801: Solum Flow - 2cc
• 00817771029761: Solum Flow - 10cc