| Primary Device ID | 03760260220309 | 
| NIH Device Record Key | 7e799bec-f1be-499e-b48b-46ea712a5b56 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | REFLECTYS | 
| Version Model Number | I CP | 
| Catalog Number | CPTYS-I | 
| 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 | 03760260220309 [Primary] | 
| GS1 | 03760260220521 [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 |