ReproBone

GUDID 05060171623373

ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 1.0cc

CERAMISYS LTD

Synthetic bone graft

• Primary Device ID: 05060171623373
• NIH Device Record Key: b1886739-3df3-4d79-8e94-dd951ec2bb38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReproBone
• Version Model Number: RBM1
• 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	05060171623373 [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