Inion GTR BioRestore™ BRS-2101

GUDID 06438408009679

Block 15 x 25 x 4 mm

Inion Oy

Synthetic bone graft

• Primary Device ID: 06438408009679
• NIH Device Record Key: 7ae0e1dc-a627-488d-a74e-2467d0c03f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion GTR BioRestore™
• Version Model Number: 1
• Catalog Number: BRS-2101
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06438408009679 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-11
• Device Publish Date: 2020-03-03

On-Brand Devices [Inion GTR BioRestore™]

• M224BRS21209: Cylinder 8x15 mm
• 06438408009686: Morsels 1.5 cc
• 06438408009679: Block 15 x 25 x 4 mm
• 06438408009662: Block 5 x 10 x 4 mm
• 06438408009693: Cylinder 8x15 mm