| Primary Device ID | 00192896116344 |
| NIH Device Record Key | 57dc579c-47d8-462e-9e3e-c8a8213310c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cooley Mitral Retractor Blade |
| Version Model Number | 2500-4754 |
| Catalog Number | 2500-4754 |
| 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 | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896116344 [Primary] |
| GAD | RETRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
[00192896116344]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2024-01-22 |
| 00192896116351 | Cooley Mitral Retractor Medium Blade 38 Millimeter X 35 Millimeter |
| 00192896116344 | Cooley Mitral Retractor Small Blade 25 Millimeter X 35 Millimeter |
| 00192896116696 | Cooley Mitral Retractor Blade Malleable Flat |
| 00192896116689 | Cooley Mitral Retractor Blade Malleable Medium Curved |
| 00192896116672 | Cooley Mitral Retractor Blade Malleable Medium Slightly Curved |
| 00192896116665 | Cooley Mitral Retractor Blade Malleable Small Curved |