| Primary Device ID | 17540208000131 |
| NIH Device Record Key | 72ffbe50-c089-45f4-b847-8900dae3ebf4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Select NanoFill |
| Version Model Number | FIL-RC-A2 |
| Catalog Number | FIL-RC-A2 |
| Company DUNS | 486717338 |
| Company Name | Zendo Direct AG |
| Device Count | 20 |
| 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 | 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature: max. 77°F (25°C) |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540208000134 [Unit of Use] |
| GS1 | 17540208000131 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-21 |
| 17540208000070 | Low shrink low abrasion light cure nano filled composite - Syringe; Shade A3 |
| 17540208000063 | Low shrink low abrasion light cure nano filled composite - Syringe; Shade A2 |
| 17540208000056 | Low shrink low abrasion light cure nano filled composite - Syringe; Shade A1 |
| 17540208000308 | Low shrink low abrasion light cure nano filled composite - Caps; Shade A1 |
| 17540208000131 | Low shrink low abrasion light cure nano filled composite - Caps; Shade A2 |