| Primary Device ID | D746IS25110401 |
| NIH Device Record Key | ee59220a-041f-4680-bdae-1f434e3039d1 |
| Commercial Distribution Discontinuation | 2019-05-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ideal Clear |
| Version Model Number | IS25-110-40 |
| Catalog Number | IS25-110-40 |
| Company DUNS | 801157132 |
| Company Name | RAINTREE ESSIX INC. |
| Device Count | 50 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746IS25110400 [Unit of Use] |
| HIBCC | D746IS25110401 [Primary] |
| KMY | POSITIONER, TOOTH, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-09-24 |
| D746IS25110801 | Ideal Clear 080 125MM Circle Biostar |
| D746IS25110411 | Ideal Clear 040 120MM Circle Erko |
| D746IS25110401 | Ideal Clear 040 125MM Circle Biostar |
| D746IS25110201 | Ideal Clear 020 125MM Circle Biostar |
| D746IS25110601 | Ideal Clear 060 125MM Circle Biostar |
| D746IS25110311 | Ideal Clear 030 120MM Circle Erko |
| D746IS25110301 | Ideal Clear 030 125MM Circle Biostar |
| D746IS25100851 | Ideal Clear 080 127MM Square |
| D746IS25100651 | Ideal Clear 060 127MM Square |
| D746IS25100451 | Ideal Clear 040 127MM Square |
| D746IS25100301 | Ideal Clear 030 125MM Square |
| D746IS25100251 | Ideal Clear 020 127MM Square |