| Primary Device ID | 00192896099043 |
| NIH Device Record Key | 9e098527-78a0-42e5-acae-36125fc58cf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SONTEC OPERATING LARYNGOSCOPE |
| Version Model Number | 485-1313 |
| Catalog Number | 485-1313 |
| 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 | 800-821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896099043 [Primary] |
| CCW | Laryngoscope, Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896099043]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-13 |
| Device Publish Date | 2019-09-05 |
| 00192896080331 | SONTEC OPERATING LARYNGOSCOPE MEDIUM SIZE |
| 00192896080324 | SONTEC OPERATING LARYNGOSCOPE SMALL SIZE |
| 00192896099043 | SONTEC OPERATING LARYNGOSCOPE ADULT SIZE |
| 00192896116306 | Sontec Operating Laryngoscope Adult Medium Size Set |
| 00192896116269 | Sontec Operating Laryngoscope Light Guide |