| Primary Device ID | 00850004223130 |
| NIH Device Record Key | ce137e70-6b55-421f-b5ee-a037c878f3cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Candid Redo Impression Kit |
| Version Model Number | RDKETTS0001 |
| 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 |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004223130 [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 | 2019-10-14 |
| Device Publish Date | 2019-10-04 |
| 00850004223093 | Redo Impression Kit (small Trays) |
| 00850004223086 | Redo Impression Kit (medium trays) |
| 00850004223079 | Redo Impression Kit (large trays) |
| 00850004223062 | Candid redo impression (medium trays) |
| 00850004223055 | Redo Impression Kit RDMDPAT00001 (Medium Trays) |
| 00850004223048 | Candid Redo Impression Kit (small trays) |
| 00850004223031 | Redo Impression Kit (Large Trays) |
| 00850004223154 | Redo Impression Kit (Large Trays) Kett Putty Digital |
| 00850004223147 | Redo Impression Kit (Medium Trays) Kett Putty Digital |
| 00850004223130 | Redo Impression Kit (Small Trays) Kett Putty Digital |