CellFUSE CF-s25x50x3

GUDID 00850005961093

CellFUSE Sheet 25mm x 50mm x 3mm

REGENACELL THERAPY INC

Synthetic bone graft

• Primary Device ID: 00850005961093
• NIH Device Record Key: a10617b9-ee66-4bd0-8482-a6b622926090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellFUSE
• Version Model Number: CF-s25x50x3
• Catalog Number: CF-s25x50x3
• 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	00850005961093 [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: 2020-10-30
• Device Publish Date: 2020-10-22

On-Brand Devices [CellFUSE]

• 00850005961109: CellFUSE Sheet 25mm x 75mm x 3mm
• 00850005961093: CellFUSE Sheet 25mm x 50mm x 3mm
• 00850005961086: CellFUSE Sheet 25mm x 25mm x 3mm