Bio-Eye®

GUDID 00854066006083

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.

INTEGRATED ORBITAL IMPLANTS INC

Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer

• Primary Device ID: 00854066006083
• NIH Device Record Key: c922f097-6f8b-4f82-9985-f44c023b53f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Eye®
• Version Model Number: I0016P
• Company DUNS: 859186348
• Company Name: INTEGRATED ORBITAL IMPLANTS INC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com
• Phone: 1-800-424-6537
• Email: haimplants@ioi.com

Device Dimensions

• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854066006083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003338

FDA Product Code

• HQN: Conformer, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-01

On-Brand Devices [Bio-Eye®]

• 00854066006120: Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations, eviscer
• 00854066006113: Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and evis
• 00854066006106: Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and evis
• 00854066006090: Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and evis
• 00854066006083: Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and evis
• 00854066006076: Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006069: Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006052: Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006045: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006038: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006021: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006014: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006007: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.