| Primary Device ID | 00817773021046 |
| NIH Device Record Key | a3c881b7-86cc-4ed4-a276-24e971d9111f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 0817773021046 |
| Version Model Number | RS3513C |
| Catalog Number | RS3513C |
| Company DUNS | 079439145 |
| Company Name | INTEGRATED DENTAL SYSTEMS, LLC |
| 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 | 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 |
| Phone | 866-277-5662 |
| ids@idsimplants.com | |
| Phone | 866-277-5662 |
| ids@idsimplants.com | |
| Phone | 866-277-5662 |
| ids@idsimplants.com | |
| Phone | 866-277-5662 |
| ids@idsimplants.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817773021046 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-21 |
| Device Publish Date | 2020-05-13 |
| 00817773026201 - Reflect Implant System | 2020-09-18 Reflect Certus 4.1 Healing Abut 6.0x4H |
| 00817773026218 - Reflect Implant System | 2020-09-18 Reflect Certus 5.0 Healing Abut 5.6x4H |
| 00817773022111 - Reflect Implant System | 2020-05-22 Reflect Certus 5.0 X 8.5 |
| 00817773022128 - Reflect Implant System | 2020-05-22 Reflect Certus 5.0 X 10 |
| 00817773022135 - Reflect Implant System | 2020-05-22 Reflect Certus 5.0 X 11.5 |
| 00817773022142 - Reflect Implant System | 2020-05-22 Reflect Certus 5.0 X 13 |
| 00817773023019 - Reflect Implant System | 2020-05-22 Reflect Recover 3.5mm X 08mmL |
| 00817773023026 - Reflect Implant System | 2020-05-22 Reflect Recover 3.5mm X 10mmL |