Bio-Eye®

GUDID 00854066006120

Orbital sphere implant

Primary Device ID	00854066006120
NIH Device Record Key	b8fda896-cfc2-45a5-8e84-647ad93139b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bio-Eye®
Version Model Number	I0024P
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

Device Issuing Agency	Device ID
GS1	00854066006120 [Primary]

MTZ	Wrap, Implant, Orbital

Steralize Prior To Use	false
Device Is Sterile	true

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.

Mark Image Registration \| Serial	Company Trademark Application Date
BIO-EYE 74523034 1941768 Live/Registered	INTEGRATED ORBITAL IMPLANTS 1994-05-02