| Primary Device ID | D798SMT1 |
| NIH Device Record Key | 05155b9d-1f39-4b32-bf6d-a2f4b0cc84a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self Mixing Tips |
| Version Model Number | SMT |
| Catalog Number | SMT |
| Company DUNS | 113170088 |
| Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
| Device Count | 15 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 630-773-4009 |
| paulgropi@aol.com | |
| Phone | 630-773-4009 |
| paulgropi@aol.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient conditions. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D798SMT0 [Unit of Use] |
| HIBCC | D798SMT1 [Primary] |
| KXR | Applicator, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2016-08-01 |
| D798SMT1 | Self Mixing Tips are intended for use in the mix / delivery of two part adhesives/cements. Qty |
| D798SMT21 | Sample Self Mixing Tips |