OPTI-VISOR DA-5
GUDID 00192896087798
OPTI-VISOR #5 2.5X MAGNIFICATION
SONTEC INSTRUMENTS, INC.
Epicardial pacing lead| Primary Device ID | 00192896087798 |
| NIH Device Record Key | bbf429a4-784f-4401-b24c-a86e35790cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTI-VISOR |
| Version Model Number | DA-5 |
| Catalog Number | DA-5 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
Device Dimensions
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896087798 [Primary] |
FDA Product Code
| LRC | INSTRUMENT, ENT MANUAL SURGICAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896087798]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
Devices Manufactured by SONTEC INSTRUMENTS, INC.
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| 00192896120990 - Liver Retractor | 2025-01-31 Liver Retractor Curved Triangle 60 Millimeter Tip 5-Star Rotary Knob |
| 00192896121041 - Endonasal DCR Instrumentation Set | 2025-01-31 Endonasal DCR Instrumentation Set Without Tray |
| 00192896121058 - Kerrison Rongeur | 2025-01-31 Kerrison Rongeur Silicone Handle Quick Release Light Weight 14 Millimeter Opening 40 Degrees Forward 2 Millimeter |
| 00192896121065 - Kerrison Rongeur | 2025-01-31 Kerrison Rongeur With Ejector Pin Thin Footplate 40 Degrees Forward 2 Millimeter x 14 Millimeter Jaw Opening |
| 00192896121072 - Tray With Brackets | 2025-01-31 Tray With Brackets Stainless Steel |
| 00192896121003 - Kerrison Rongeur | 2025-01-14 Kerrison Rongeur With Ejector Pin Silicone Handle Internal Spring 14 Millimeter Opening 40 Degree Forward Thin Footplate |
Trademark Results [OPTI-VISOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTI-VISOR 85193017 4173766 Live/Registered |
S. A. Armstrong Limited 2010-12-08 |
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