| Primary Device ID | 00841549115936 |
| NIH Device Record Key | 06ae1847-289f-4ebd-b9cf-e5750df06a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SternVantage® Impression Mat'l |
| Version Model Number | 220162 |
| Company DUNS | 124763728 |
| Company Name | STERNGOLD DENTAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 00841549115936 [Primary] |
| ELW | Material, 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 | 2023-07-26 |
| Device Publish Date | 2023-07-18 |