CellFUSE™ CF-G10

GUDID 00850005961055

CellFUSE™ Granules 10cc

REGENACELL THERAPY INC

Synthetic bone graft

• Primary Device ID: 00850005961055
• NIH Device Record Key: 1c2c4dd4-3058-42a6-b992-62cabf6355b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellFUSE™
• Version Model Number: CF-G10
• Catalog Number: CF-G10
• Company DUNS: 018987812
• Company Name: REGENACELL THERAPY 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005961055 [Primary]

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: 2019-04-15
• Device Publish Date: 2019-04-05

On-Brand Devices [CellFUSE™]

• 00850005961079: CellFUSE™ Granules 30cc
• 00850005961062: CellFUSE™ Granules 20cc
• 00850005961055: CellFUSE™ Granules 10cc
• 00850005961048: CellFUSE™ Granules 5cc
• 00850005961031: CellFUSE™ Sheet 25mm x 125mm x 5mm
• 00850005961024: CellFUSE™ Sheet 25mm x 75mm x 5mm
• 00850005961017: CellFUSE™ Sheet 25mm x 50mm x 5mm
• 00850005961000: CellFUSE™ Sheet 25mm x 25mm x 5mm