ReproBone

GUDID 05060171623359

ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 0.25cc

CERAMISYS LTD

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: 05060171623359
• NIH Device Record Key: ca50bc54-121e-444f-9cef-b99fb1ed3838
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReproBone
• Version Model Number: RBM025
• Company DUNS: 423459374
• Company Name: CERAMISYS LTD
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171623359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103820

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-31

On-Brand Devices [ReproBone]

• 05060171623410: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 5cc
• 05060171623403: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 3.0cc
• 05060171623397: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 2.5cc
• 05060171623380: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 2.0cc
• 05060171623373: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 1.0cc
• 05060171623366: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 0.5cc
• 05060171623359: ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 0.25cc
• 05060171623342: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 5cc
• 05060171623335: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 3.0cc
• 05060171623328: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.5cc
• 05060171623311: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.0cc
• 05060171623304: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 1.0cc
• 05060171623298: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.5cc
• 05060171623281: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.25cc