| Primary Device ID | 00192896031920 |
| NIH Device Record Key | 69e04637-3066-489e-b4a0-a52074b1bb9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEIVERT ANDERSON OSTEOTOME |
| Version Model Number | 350-824 |
| Catalog Number | 350-824 |
| 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 | 8 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896031920 [Primary] |
| HWM | OSTEOTOME |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896031920]
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 | 2018-09-13 |
| 00192896078413 | NEIVERT ANDERSON OSTEOTOME WITH SINGLE GUARD NARROW LEFT CURVED TIP |
| 00192896078406 | NEIVERT ANDERSON OSTEOTOME WITH SINGLE GUARD NARROW RIGHT CURVED TIP |
| 00192896031944 | NEIVERT ANDERSON OSTEOTOME SINGLE GUARD STRAIGHT TIP |
| 00192896031937 | NEIVERT ANDERSON OSTEOTOME SINGLE GUARD LEFT CURVED TIP |
| 00192896031920 | NEIVERT ANDERSON OSTEOTOME SINGLE GUARD RIGHT CURVED TIP |
| 00192896101562 | NEIVERT ANDERSON OSTEOTOME WITH GUARD NARROW STRAIGHT TIP |