Inion OTPS BioRestore™ BRS-1611

GUDID 06438408009600

Morsels 1.5 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

• Primary Device ID: 06438408009600
• NIH Device Record Key: ffc8a27a-8911-4375-9520-9a202978c042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-1611
• 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	06438408009600 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Inion OTPS BioRestore™]

• M224BRS16209: Cylinder 8x15 mm
• M224BRS16119: Morsels 1.5 cc
• M224BRS16109: Morsels 4.5 cc
• M224BRS16019: Block 60x40x8 mm
• M224BRS16009: Block 30 x 20 x 8 mm
• 06438408009617: Block 5 x 10 x 4 mm
• 06438408009600: Morsels 1.5 cc
• 06438408009594: Morsels 4.5 cc
• 06438408009068: Cylinder 8x15 mm
• 06438408009051: Block 60x40x8 mm
• 06438408007941: Block 30 x 20 x 8 mm