| Primary Device ID | 00192896071674 |
| NIH Device Record Key | 280fc0c3-4802-499f-a302-33f953de8375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LED MICROLIGHT |
| Version Model Number | J-008.31.286 |
| Catalog Number | J-008.31.286 |
| 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 |
| 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 | 00192896071674 [Primary] |
| EQH | SOURCE, CARRIER, FIBEROPTIC LIGHT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896071674]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00192896071674 | LED MICROLIGHT ON LIGHT WEIGHT HEADBAND WITHOUT CASE |
| 00192896071643 | LED MIRCOLIGHT LIGHT WEIGHT HEADBAND WITH MPACK LL & TRANSFORMER |
| 00192896071636 | LED MICROLIGHT ON S-FRAME WITH MPACK LL |