| Primary Device ID | 00192896050419 |
| NIH Device Record Key | c7ff21a6-e3a3-455f-ae15-e411a4911705 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | McCALL CURETTE |
| Version Model Number | 1102-RESCM17S-18S |
| Catalog Number | 1102-RESCM17S-18S |
| 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 | 00192896050419 [Primary] |
| EMK | CURETTE, SURGICAL, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896050419]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-09 |
| Device Publish Date | 2018-09-17 |
| 00192896082403 | MCCALL CURETTE #17-18 DOUBLE ENDED BLADES |
| 00192896050419 | McCALL CURETTE #17S-18S DOUBLE ENDED STRAIGHT SIDED UNIVERSAL BLADE ROUND TOE CURVATURE SHANK LI |
| 00192896050402 | McCALL CURETTE #17-18 DOUBLE ENDED ELLIPTICAL BLADE ROUND TOE CURVATURE SHANK LIGHT HANDLE |
| 00192896089440 | MCCALL CURETTE #17-18 DOUBLE ENDED ELLIPTICAL BLADE ROUND TOE CURVATURE SHANK |