| Primary Device ID | 00192896078567 |
| NIH Device Record Key | 7777e7ee-65e2-4d36-8c9d-3664e43dff75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BAYONET SPINAL KNIFE HANDLE |
| Version Model Number | 400-428 |
| Catalog Number | 400-428 |
| 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 | 13.75 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896078567 [Primary] |
| EMF | KNIFE, SURGICAL |
| GDZ | Handle, Scalpel |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896078567]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-03-08 |
| Device Publish Date | 2018-09-20 |
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