| Primary Device ID | 00192896031999 |
| NIH Device Record Key | be016daf-d421-46c8-8660-b2d70414e063 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCHROM OSTEOTOME |
| Version Model Number | 350-835ST |
| Catalog Number | 350-835ST |
| 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 | 00192896031999 [Primary] |
| HWM | OSTEOTOME |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896031999]
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 |
| 00192896078451 | SCHROM OSTEOTOME WITH GUIDE STRAIGHT TIP BLACK CERAMITEC COATED |
| 00192896031999 | SCHROM OSTEOTOME WITH GUIDE STRAIGHT TIP |
| 00192896031982 | SCHROM OSTEOTOME WITH GUIDE CURVED RIGHT SIDE BLACK CERAMIC COATED |
| 00192896031975 | SCHROM OSTEOTOME WITH GUIDE CURVED FOR RIGHT SIDE |
| 00192896031968 | SCHROM OSTEOTOME WITH GUIDE CURVED FOR LEFT SIDE BLACK CERAMIC COATED |
| 00192896031951 | SCHROM OSTEOTOME WITH GUIDE CURVED FOR LEFT SIDE |