Inion CPS BioRestore™ BRS-1400

GUDID M224BRS14009

Block 15x25x4 mm

Inion Oy

Synthetic bone graft

• Primary Device ID: M224BRS14009
• NIH Device Record Key: 179c29e1-7936-4656-9eb1-d54209a373d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion CPS BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-1400
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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: true
• Expiration Date: true
• Donation Id Number: false
• 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
HIBCC	M224BRS14009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070784

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion CPS BioRestore™]

• M224BRS14019: Block 30x20x8 mm
• M224BRS14009: Block 15x25x4 mm
• 06438408009655: Morsels 4.5 cc
• 06438408009648: Block 30x20x8 mm
• 06438408009631: Block 15x25x4 mm