| Primary Device ID | 00850004223116 |
| NIH Device Record Key | 9aac0c2f-8148-4275-a44b-90aa8e9bcb16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Candid Impression Kit |
| Version Model Number | IKMESHFINISHED00002 |
| Company DUNS | 108729170 |
| Company Name | CANDID CARE CO. |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Phone | 917-754-2056 |
| dan.michaeli@candidco.com |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004223116 [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 | 2019-11-06 |
| Device Publish Date | 2019-10-29 |
| 00850004223017 | Candid finished impression kit |
| 00850004223109 | Candid finished impression kit (Mesh Impression Tray) |
| 00850004223123 | Candid finished impression kit (Old Tray + Kett Putty + Digital) |
| 00850004223185 | Candid finished impression kit (Old Tray + Kett Putty + Digital) |
| 00850004223116 | Candid finished impression kit (Mesh Impression Tray + Kett Putty) |
| 00850004223000 | Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush) |
| 00850004223178 | Candid finished impression kit (Mesh Impression Tray Low + Reg Impression Tray Up) |
| 00850004223161 | Candid finished impression kit (Old Tray + Kulz Putty + Digital) |
| 00850004223024 | August 2020 Promo |
| 00850004223789 | Impression Kit (Medium Trays) Zest Putty Digital |
| 00850004223345 | Candid finished impression kit (New Light Blue Tray + Kett Putty + Digital) |