| Primary Device ID | 00192896031340 |
| NIH Device Record Key | 0676f1fc-52ea-433a-ab75-6dc67de0aa8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUMBAR/CERVICAL IMPACTOR |
| Version Model Number | 335-391 |
| Catalog Number | 335-391 |
| 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 | 00192896031340 [Primary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896031340]
Moist Heat or Steam Sterilization;Dry Heat 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 |
| 00192896031401 | LUMBAR/CERVICAL IMPACTOR WIDE LATERAL |
| 00192896031395 | LUMBAR/CERVICAL IMPACTOR WIDE LATERAL |
| 00192896031388 | LUMBAR/CERVICAL IMPACTOR GUARDED MICROSCOPIC LATERAL |
| 00192896031371 | LUMBAR/CERVICAL IMPACTOR MICROSCOPIC LATERAL OFFSET |
| 00192896031364 | LUMBAR/CERVICAL IMPACTOR MICRO LATERAL OFFSET WITH HEEL |
| 00192896031357 | LUMBAR/CERVICAL IMPACTOR MICRO LATERAL OFFSET WITHOUT HEEL |
| 00192896031340 | LUMBAR/CERVICAL IMPACTOR LATERAL NARROW TIPS |
| 00192896031333 | LUMBAR/CERVICAL IMPACTOR |