Inion BioRestore™ BRS-5431

GUDID M224BRS54319

Morsels 4.5 cc

Inion Oy

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 Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: M224BRS54319
• NIH Device Record Key: c4c781f6-aa2f-4516-870d-4517d8ee8792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-5431
• 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
GS1	06438408003097 [Secondary]
HIBCC	M224BRS54319 [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: 4
• Public Version Date: 2019-11-15
• 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