| Primary Device ID | 00192896057265 |
| NIH Device Record Key | 45e8546d-acfb-41a0-860e-e59db466a713 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NASAL/TENDON KNIFE |
| Version Model Number | 1271-180 |
| Catalog Number | 1271-180 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896057265 [Primary] |
| HTS | KNIFE, ORTHOPEDIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896057265]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-12 |
| Device Publish Date | 2018-09-11 |
| 00192896057272 | NASAL/TENDON KNIFE SINGLE RETROGRAD CURVED EDGE |
| 00192896057265 | NASAL/TENDON KNIFE SINGLE LANCE STRAIGHT EDGE |
| 00192896057241 | NASAL/TENDON KNIFE SINGLE CLASSIC STRAIGHT EDGE |
| 00192896057234 | NASAL/TENDON KNIFE SINGLE STRAIGHT EDGE |
| 00192896057159 | NASAL/TENDON KNIFE DOUBLE LANCE STRAIGHT EDGE |
| 00192896115347 | Nasal/Tendon Knife Double Lance Edge Straight Blade Ceramic Coating |