Orbital Implant Inserter

GUDID 05060171621850

Orbital Implant Inserter

CERAMISYS LTD

Orbital sphere implant introducer

• Primary Device ID: 05060171621850
• NIH Device Record Key: 180e6e1c-6e10-4286-835b-c7cd0af09d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbital Implant Inserter
• Version Model Number: INSTR01
• Company DUNS: 423459374
• Company Name: CERAMISYS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171621850 [Primary]

FDA Product Code

• HNP: Introducer, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-07-31

Devices Manufactured by CERAMISYS LTD

• 05060171621867 - Hydroxyapatite Orbital Implant: 2018-07-06 Porous Hydroxyapatite Orbital Implant, Sphere, 14mm
• 05060171621874 - Hydroxyapatite Orbital Implant: 2018-07-06 Porous Hydroxyapatite Orbital Implant, Sphere, 16mm
• 05060171621881 - Hydroxyapatite Orbital Implant: 2018-07-06 Porous Hydroxyapatite Orbital Implant, Sphere, 18mm
• 05060171621898 - Hydroxyapatite Orbital Implant: 2018-07-06 Porous Hydroxyapatite Orbital Implant, Sphere, 20mm
• 05060171621904 - Hydroxyapatite Orbital Implant: 2018-07-06 Porous Hydroxyapatite Orbital Implant, Sphere, 22mm
• 05060171621911 - Alumina Orbital Implant: 2018-07-06 Porous Alumina Orbital Implant, Sphere, 14mm
• 05060171621928 - Alumina Orbital Implant: 2018-07-06 Porous Alumina Orbital Implant, Sphere, 16mm
• 05060171621935 - Alumina Orbital Implant: 2018-07-06 Porous Alumina Orbital Implant, Sphere, 18mm