| Primary Device ID | 00192896078123 |
| NIH Device Record Key | 221005e2-72f7-447c-81ae-5420b09a0181 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SONTEC MALLET |
| Version Model Number | 330-824 |
| Catalog Number | 330-824 |
| 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 |
| Outer Diameter | 1.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896078123 [Primary] |
| HXL | MALLET |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896078123]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-20 |
| 00192896078154 | SONTEC MALLET LARGE RIBBED PHENOLIC HANDLE |
| 00192896078130 | SONTEC MALLET LARGE SIZE WITH REMOVEABLE STEEL/NYLON HEADS |
| 00192896078123 | SONTEC MALLET LARGE SIZE WITH NYLON HEAD |
| 00192896030824 | SONTEC LARGE HANDLE MALLET ERGONOMIC PHENOLIC HANDLE |
| 00192896030817 | SONTEC MALLET RIBBED LARGE PHENOLIC HANDLE |
| 00192896030800 | SONTEC MALLET LARGE HANDLE |
| 00192896030749 | SONTEC MALLET NO RECOIL LEAD FILLED HEAD |
| 00192896030725 | SONTEC MALLET CONVEX/FLAT HEAD STAINLESS STEEL |
| 00192896030695 | SONTEC MALLET DOUBLE NYLON HEAD |