Bio-Eye®
GUDID 00854066006083
Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
Ophthalmic conformer| Primary Device ID | 00854066006083 |
| NIH Device Record Key | c922f097-6f8b-4f82-9985-f44c023b53f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Eye® |
| Version Model Number | I0016P |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854066006083 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003338
FDA Product Code
| HQN | Conformer, Ophthalmic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-12-01 |
On-Brand Devices [Bio-Eye®]
| 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. |
Trademark Results [Bio-Eye]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-EYE 74523034 1941768 Live/Registered |
INTEGRATED ORBITAL IMPLANTS 1994-05-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.