GUDID 00854066006151

INTEGRATED ORBITAL IMPLANTS INC

Ophthalmic conformer

• Primary Device ID: 00854066006151
• NIH Device Record Key: 4c620a95-8732-4257-9103-1d891bcdc320
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I00043
• Company DUNS: 859186348
• Company Name: INTEGRATED ORBITAL IMPLANTS INC
• 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: false
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854066006151 [Primary]

FDA Product Code

• HQN: Conformer, Ophthalmic

Sterilization

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

[00854066006151]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-12-01

Devices Manufactured by INTEGRATED ORBITAL IMPLANTS INC

• 00854066006236 - P-K Titanium Motility Peg System: 2024-03-25 Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded
• 00854066006007 - Bio-Eye®: 2018-07-06 Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006014 - Bio-Eye®: 2018-07-06 Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006021 - Bio-Eye®: 2018-07-06 Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006038 - Bio-Eye®: 2018-07-06 Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006045 - Bio-Eye®: 2018-07-06 Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006052 - Bio-Eye®: 2018-07-06 Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
• 00854066006069 - Bio-Eye®: 2018-07-06 Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.