| Primary Device ID | 00192896120600 |
| NIH Device Record Key | c853b689-66fa-4cf4-8332-cf986878aa65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cooley Mitral Valve Retractor Blades |
| Version Model Number | 2500-326 |
| Catalog Number | 2500-326 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896120600 [Primary] |
| GAD | RETRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
[00192896120600]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
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| 00192896121713 - MIS Inner Ear Suction Dissector | 2025-07-25 MIS Inner Ear Suction Dissector For Tympanum Single Curved Right 3 Millimeter 6.2 Millimeter |
| 00192896121720 - MIS Inner Ear Suction Dissector | 2025-07-25 MIS Inner Ear Suction Dissector For Sinus Tympani Double Curved Backward Left 3 Millimeter 6.2 Millimeter |
| 00192896121737 - MIS Inner Ear Suction Dissector | 2025-07-25 MIS Inner Ear Suction Dissector For Sinus Tympani Double Curved Backward Right 3 Millimeter 6.2 Millimeter |
| 00192896121744 - MIS Inner Ear Suction Dissector | 2025-07-25 MIS Inner Ear Suction Dissector For Atticus Double Curved Forward Right 3 Millimeter 6.2 Millimeter |
| 00192896121751 - MIS Inner Ear Suction Dissector | 2025-07-25 MIS Inner Ear Suction Dissector For Tympanum Right Curved Extra Fine Luer Lock |