| Primary Device ID | 00192896042995 |
| NIH Device Record Key | 27a579e6-6a73-4cb9-89a7-ae1e8cf68bfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SILVER OSTEOTOME |
| Version Model Number | 475-798 |
| Catalog Number | 475-798 |
| 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 | 00192896042995 [Primary] |
| KDG | CHISEL (OSTEOTOME) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896042995]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-15 |
| Device Publish Date | 2018-09-12 |
| 00192896078444 | SILVER OSTEOTOME WITH SINGLE GUARD RIGHT CURVED TIP |
| 00192896078437 | SILVER OSTEOTOME WITH SINGLE GUARD LEFT CURVED TIP |
| 00192896078420 | SILVER OSTEOTOME WITH SINGLE GUARD STRAIGHT TIP |
| 00192896042995 | SILVER OSTEOTOME SINGLE GUARD BLADE RIGHT CURVED TIP |
| 00192896042988 | SILVER OSTEOTOME SINGLE GUARD BLADE LEFT CURVED TIP |
| 00192896042971 | SILVER OSTEOTOME SINGLE GUARD BLADE STRAIGHT TIP |