| Primary Device ID | 00850004223086 |
| NIH Device Record Key | 97104b5f-0444-45ee-bb4e-0d3cd3cb476d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Candid Redo Impression Kit |
| Version Model Number | UBRD0002 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9177542056 |
| dan.michaeli@candidco.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004223086 [Primary] |
| EIG | Retractor, All Types |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-03-01 |
| 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 |