CellFUSE CF-s25x25x3

GUDID 00850005961086

CellFUSE Sheet 25mm x 25mm x 3mm

REGENACELL THERAPY INC

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: 00850005961086
• NIH Device Record Key: 1379ca58-bf8b-43d2-9a18-0a369ed3cf2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellFUSE
• Version Model Number: CF-s25x25x3
• Catalog Number: CF-s25x25x3
• 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	00850005961086 [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