| Primary Device ID | 03760260220194 |
| NIH Device Record Key | 9b2ba0b7-fc1e-40a5-a822-43f7df81e64e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REFLECTYS |
| Version Model Number | A3.5 CP |
| Catalog Number | CPTYS-A3.5 |
| Company DUNS | 278261221 |
| Company Name | ITENA CLINICAL |
| Device Count | 20 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760260220194 [Primary] |
| GS1 | 03760260220415 [Unit of Use] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-11-10 |
| Device Publish Date | 2016-10-15 |
| 03760260220316 | P CP |
| 03760260220309 | I CP |
| 03760260220293 | E CP |
| 03760260220286 | A3O CP |
| 03760260220279 | A2O CP |
| 03760260220262 | D3 CP |
| 03760260220255 | C3 CP |
| 03760260220248 | C2 CP |
| 03760260220231 | B3 CP |
| 03760260220224 | B2 CP |
| 03760260220217 | B1 CP |
| 03760260220200 | A4 CP |
| 03760260220194 | A3.5 CP |
| 03760260220187 | A3 CP |
| 03760260220170 | A2 CP |
| 03760260220163 | A1 CP |
| 03760260220156 | P |
| 03760260220149 | I |
| 03760260220132 | E |
| 03760260220125 | A30 |
| 03760260220118 | A20 |
| 03760260220101 | D3 |
| 03760260220095 | C3 |
| 03760260220088 | C2 |
| 03760260220071 | B3 |
| 03760260220064 | B2 |
| 03760260220057 | B1 |
| 03760260220040 | A4 |
| 03760260220033 | A3.5 |
| 03760260220026 | A3 |
| 03760260220019 | A2 |
| 03760260220002 | A1 |