| Primary Device ID | 08642060004066 |
| NIH Device Record Key | e7fb3fd6-61fb-4bb5-ba74-b9cebbfba935 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heron IOS |
| Version Model Number | IOS-FP-71-001 |
| Company DUNS | 117033482 |
| Company Name | 3D IMAGING AND SIMULATION CORP. AMERICAS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 | +1 800 570 0363 |
| info@3disc.com |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08642060004066 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08642060004066]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2019-09-13 |
| 08642060004066 | Heron IOS system is an optical impression system used to record the topographical characteristi |
| 00864206000406 | Heron IOS system is an optical impression system used to record the topographical characteristi |