Bio-Eye®

GUDID 00854066006014

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

INTEGRATED ORBITAL IMPLANTS INC

Ophthalmic conformer
Primary Device ID00854066006014
NIH Device Record Key65ac103d-769b-426a-b028-fad3bfeda6bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Eye®
Version Model NumberI00018S
Company DUNS859186348
Company NameINTEGRATED ORBITAL IMPLANTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-424-6537
Emailhaimplants@ioi.com

Device Dimensions

Outer Diameter18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100854066006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-01

On-Brand Devices [Bio-Eye®]

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

Trademark Results [Bio-Eye]

Mark Image

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

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