Inion BioRestore™ BRS-5413

GUDID M224BRS54139

Oval 7 mm

Inion Oy

Synthetic bone graft

• Primary Device ID: M224BRS54139
• NIH Device Record Key: 195c0301-0e39-4d28-a450-8d0ce48276fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-5413
• 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	M224BRS54139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070998

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion BioRestore™]

• M224BRS54609: Oval, small 4 mm
• M224BRS54319: Morsels 4.5 cc
• M224BRS54309: Morsels 1.5 cc
• M224BRS54139: Oval 7 mm
• 06438408009327: Cylinder 8 x 15 mm
• 06438408009310: Block 60 x 40 x 8 mm
• 06438408009303: Block 30 x 20 x 8 mm
• 06438408009297: Block 15 x 25 x 4 mm
• 06438408009280: Block 5 x 10 x 4 mm
• 06438408009273: Block, Wedge 13 mm
• 06438408009266: Block, Wedge 4 mm
• 06438408009259: Block, Gradient 13 mm
• 06438408009242: Block, Gradient 4 mm
• 06438408009013: Oval 13 mm
• 06438408009006: Oval 9 mm
• 06438408008993: Oval 8 mm
• 06438408008979: Oval 6 mm
• 06438408008962: Oval 5 mm
• 06438408008955: Oval 4 mm
• 06438408009334: Oval, small 4 mm
• 06438408008986: Oval 7 mm
• 06438408003097: Morsels 4.5 cc
• 06438408003080: Morsels 1.5 cc