| Primary Device ID | DO3686505081 |
| NIH Device Record Key | aac41a15-2f32-4425-8909-75dc800cda8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIVA LUTING |
| Version Model Number | RIVA LUTING P/L KT LARGE |
| Catalog Number | 8650508 |
| Company DUNS | 753221852 |
| Company Name | SDI LIMITED |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | +18002285166 |
| info@sdi.com.au |
| Handling Environment Atmospheric Pressure | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | DO3686505081 [Primary] |
| EMA | CEMENT, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-07 |
| DO3686519001 | RIVA LUTING PLUS LQD REF 10G |
| DO3686515081 | RIVA LUTING PLUS P/L KT |
| DO3686511081 | RIVA LUTING PLUS PWD REF 25G |
| DO3686510081 | RIVA LUTING PLUS 50 CAP |
| DO3686509001 | RIVA LUTING LQD REF 25G |
| DO3686505101 | RIVA LUTING P/L TRIPLE PK |
| DO3686505081 | RIVA LUTING P/L KT LARGE |
| DO3686501081 | RIVA LUTING LY PWD REF 35 |
| DO3686500081 | RIVA LUTING LY 50 CAP |