Bio-Eye®

GUDID 00854066006014

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

INTEGRATED ORBITAL IMPLANTS INC

Ophthalmic conformer

• Primary Device ID: 00854066006014
• NIH Device Record Key: 65ac103d-769b-426a-b028-fad3bfeda6bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Eye®
• Version Model Number: I00018S
• 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

Device Dimensions

• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854066006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982562

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: 3
• 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.