| Primary Device ID | 00192896080157 | 
| NIH Device Record Key | 587e96a5-0fcf-4e2f-b75e-7cd0d3bdbe5c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SONTEC EAR RASPATORY | 
| Version Model Number | 475-610 | 
| Catalog Number | 475-610 | 
| 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 | 
| Length | 7.25 Inch | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00192896080157 [Primary] | 
| JYY | RASP, EAR | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896080157]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-12-07 | 
| Device Publish Date | 2018-09-20 | 
| 00192896080157 | SONTEC EAR RASPATORY RIGHT CURVED TIP | 
| 00192896042544 | SONTEC EAR RASPATORY SERRATED CURVED RIGHT SHAFT | 
| 00192896042537 | SONTEC EAR RASPATORY SERRATED CURVED LEFT SHAFT | 
| 00192896042520 | SONTEC EAR RASPATORY SERRATED CURVED RIGHT SHAFT | 
| 00192896042513 | SONTEC EAR RASPATORY SERRATED CURVED LEFT SHAFT |