Endo Optiks®
GUDID 30886158016145
23 Gauge Laser Endoscope
BEAVER-VISITEC INTERNATIONAL, INC.
Rigid ophthalmic endoscope| Primary Device ID | 30886158016145 |
| NIH Device Record Key | 330eda0f-3fc1-40c3-bdac-07b6fcc38e0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo Optiks® |
| Version Model Number | OME230SMAXA |
| Company DUNS | 001406024 |
| Company Name | BEAVER-VISITEC INTERNATIONAL, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30886158016145 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K910532
FDA Product Code
| HQP | Unit, cautery, thermal, battery-powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [Endo Optiks®]
| 30886158016251 | 23 Gauge Wide Field Illumination Probe |
| 30886158016244 | 20 Gauge Wide Field Illumination Probe |
| 30886158016237 | 23 Gauge Laser Probe |
| 30886158016220 | 25 Gauge Laser Probe |
| 30886158016213 | 23 Gauge Wide Field Illuminated Laser Probe |
| 30886158016206 | 20 Gauge Wide Field Illuminated Laser Probe |
| 30886158016190 | 18 Gauge High Resoluton Laser Endoscope |
| 30886158016183 | 18 Gauge High Resoluton Laser Endoscope |
| 30886158016176 | 23 Gauge High Resoluton Endoscope |
| 30886158016169 | 23 Gauge High Resoluton Laser Endoscope |
| 30886158016152 | 23 Gauge Endoscope |
| 30886158016145 | 23 Gauge Laser Endoscope |
| 30886158016138 | 19 Gauge High Resoluton Laser Endoscope |
| 30886158016121 | 19 Gauge High Resoluton Laser Endoscope |
| 30886158016114 | 20 Gauge High Resoluton Endoscope |
| 30886158016107 | 19 Gauge High Resoluton Laser Endoscope |
| 30886158016091 | 19 Gauge High Resoluton Laser Endoscope |
| 30886158016084 | 19 Gauge Endoscope |
| 30886158016077 | 20 Gauge Endoscope |
| 30886158016060 | 19 Gauge Laser Endoscope |
| 30886158016053 | 20 Gauge Laser Endoscope |
| 30886158016046 | 19 Gauge Laser Endoscope |
| 30886158016039 | 20 Gauge Laser Endoscope |
| 30886158016022 | E4 Endoscopy System |
| 30886158016015 | E2 Laser Endoscopy System |
Trademark Results [Endo Optiks]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDO OPTIKS 74247871 1783346 Live/Registered |
BEAVER-VISITEC INTERNATIONAL, INC. 1992-02-20 |
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