| Primary Device ID | 00192896080256 |
| NIH Device Record Key | 0ab081ce-c550-4940-8b0c-cc9a4ef357b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLASTIC SURGERY OSTEOTOME |
| Version Model Number | 475-782 |
| Catalog Number | 475-782 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896080256 [Primary] |
| HWM | OSTEOTOME |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896080256]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-04 |
| Device Publish Date | 2018-09-20 |
| 00192896080256 | PLASTIC SURGERY OSTEOTOME STRAIGHT SINGLE GUARDED TIP |
| 00192896042964 | PLASTIC SURGERY OSTEOTOME WITHOUT GUARD CURVED TIP |
| 00192896042957 | PLASTIC SURGERY OSTEOTOME WITHOUT GUARD CURVED TIP |
| 00192896042940 | PLASTIC SURGERY OSTEOTOME WITHOUT GUARD CURVED TIP |
| 00192896042889 | PLASTIC SURGERY OSTEOTOME SINGLE GUARD BLADE LEFT CURVED TIP |
| 00192896042872 | PLASTIC SURGERY OSTEOTOME SINGLE GUARD BLADE RIGHT CURVED TIP |
| 00192896042865 | PLASTIC SURGERY OSTEOTOME SINGLE GUARD BLADE LEFT CURVED TIP |
| 00192896042858 | PLASTIC SURGERY OSTEOTOME SINGLE GUARD BLADE RIGHT CURVED TIP |