| Primary Device ID | 08809917144621 |
| NIH Device Record Key | 5283a725-b088-4d0a-9e3e-69ecb25baf23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HySil Plus Impression Materials |
| Version Model Number | ESS50HSD |
| Company DUNS | 694893867 |
| Company Name | Osstem Implant Co.,Ltd. |
| 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 | true |
| 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 | 08809917144621 [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 | 2023-11-22 |
| Device Publish Date | 2023-11-14 |
| 08800121709309 | ESS50MSB |
| 08800121709293 | ESS50HSB |
| 08800121709286 | ESS50LSB |
| 08800121709279 | ESS50LSD |
| 08800121709262 | ESS50LS |
| 08800121709255 | ESS50HS |
| 08800121709248 | ESS380HS |
| 08800121709231 | ESS50MS |
| 08800121709224 | ESS50MSD |
| 08800121709217 | ESS50HSD |
| 08809917144638 | ESS50HS |
| 08809917144621 | ESS50HSD |
| 08809917144614 | ESS50HSB |
| 08809917144607 | ESS50LS |
| 08809917144591 | ESS50LSD |
| 08809917144584 | ESS50LSB |
| 08809917144577 | ESS50MS |
| 08809917144560 | ESS50MSD |
| 08809917144553 | ESS50MSB |
| 08800121773621 | ESS380MS |