Primary Device ID | 00854066006090 |
NIH Device Record Key | a4f9358a-4be9-4366-a88e-6d65a025167c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bio-Eye® |
Version Model Number | I0018P |
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 |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com | |
Phone | 1-800-424-6537 |
haimplants@ioi.com |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Outer Diameter | 18 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854066006090 [Primary] |
HQN | Conformer, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-12-01 |
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 |