| Primary Device ID | 00192896043909 |
| NIH Device Record Key | 60afa50c-21ad-40c9-b649-2c35b61e2bc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WIEDER TONGUE DEPRESSOR |
| Version Model Number | 485-590 |
| Catalog Number | 485-590 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896043909 [Primary] |
| FMA | DEPRESSOR, TONGUE, NON-SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896043909]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00192896080386 | WIEDER TONGUE DEPRESSOR LARGE SIZE |
| 00192896043923 | WIEDER TONGUE DEPRESSOR WITH SUCTION LARGE SHAFT WIDE FLARED DEPRESSING TIP |
| 00192896043916 | WIEDER TONGUE DEPRESSOR LARGE SHAFT WIDE FLARED DEPRESSING TIP |
| 00192896043909 | WIEDER TONGUE DEPRESSOR SMALL SHAFT WIDE FLARED DEPRESSING TIP |
| 00192896106185 | Wieder Tongue Depressor With Light Guide |