GUDID 00854066006151

INTEGRATED ORBITAL IMPLANTS INC

Ophthalmic conformer
Primary Device ID00854066006151
NIH Device Record Key4c620a95-8732-4257-9103-1d891bcdc320
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberI00043
Company DUNS859186348
Company NameINTEGRATED ORBITAL IMPLANTS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100854066006151 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854066006151]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-12-01

Devices Manufactured by INTEGRATED ORBITAL IMPLANTS INC

00854066006236 - P-K Titanium Motility Peg System2024-03-25 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.

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