Orbtex Orbital Implant

GUDID 05060171621966

Porous alumina orbital implant with suture platform, sphere, 16mm

CERAMISYS LTD

Orbital sphere implant

• Primary Device ID: 05060171621966
• NIH Device Record Key: 29e687a0-fcd2-4f46-b9c2-7c9fd7e7bd4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbtex Orbital Implant
• Version Model Number: RPX16
• 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 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171621966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110554

FDA Product Code

• HPZ: Implant, Eye Sphere

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 [Orbtex Orbital Implant]

• 05060171621997: Porous alumina orbital implant with suture platform, sphere, 22mm
• 05060171621980: Porous alumina orbital implant with suture platform, sphere, 20mm
• 05060171621973: Porous alumina orbital implant with suture platform, sphere, 18mm
• 05060171621966: Porous alumina orbital implant with suture platform, sphere, 16mm