| Primary Device ID | 00850047788436 |
| NIH Device Record Key | 499d4b55-c6a3-4f1a-ad65-8083511972ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Silicast Hardener |
| Version Model Number | NA |
| Catalog Number | 10402 |
| Company DUNS | 007087497 |
| Company Name | Westone Laboratories, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850047788436 [Primary] |
| LDG | Kit, Earmold, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00850047788153 - Silicone SINGLES 24 Pack | 2023-09-04 Earmold Impression material 24 Package |
| 00850047788160 - Silicone SINGLES 100 Pack | 2023-09-04 Earmold Impression Material 100 package |
| 00850047788177 - Pink Silicast | 2023-09-04 Pink Silicast Impression Material - two 335g tubs |
| 00850047788184 - Pink Silicast | 2023-09-04 Pink Silicast Impression Material - two 525g tubs |
| 00850047788191 - EZ Mold Singles 24 Pk Black | 2023-09-04 EZ Mold Single, Black 24 pack |
| 00850047788207 - EZ Mold Singles 24 Pk Beige | 2023-09-04 EZ Mold Singles 24 Pk Beige |
| 00850047788214 - EZ Mold Singles 24 Pk Pink | 2023-09-04 EZ Mold Singles 24 Pk Pink |
| 00850047788221 - EZ Mold Singles 24 Pk Purple | 2023-09-04 EZ Mold Singles 24 Pk Purple |