| Primary Device ID | D832INTM230 |
| NIH Device Record Key | 0f191116-be26-4467-a657-5eb56436ebb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONOVAC |
| Version Model Number | INT-M23 |
| Catalog Number | INT-M23 |
| Company DUNS | 190377184 |
| Company Name | PLASDENT CORPORATION |
| Device Count | 100 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D832INTM230 [Unit of Use] |
| HIBCC | D832INTM231 [Primary] |
| DZM | Needle, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
| D832INTMPT03300 | Pre-Tipped Irrigator Syringe, 3cc, 30ga, Side Vented, Monoject Style |
| D832INTMPT03270 | Pre-Tipped Irrigator Syringe, 3cc, 27ga, Side Vented, Monoject Style |
| D832INTMPT03230 | Pre-Tipped Irrigator Syringe, 3cc, 23ga, Side Vented, Monoject Style |
| D832INTM300 | Monovac Irrigator Tips, 30ga, Purple, Side Vented, Monoject Style |
| D832INTM270 | Monovac Irrigator Tips, 27ga, Yellow, Side Vented, Monoject Style |
| D832INTM230 | Monovac Irrigator Tips, 23ga, Blue, Side Vented, Monoject Style |
| D832INTSMPT03300 | Pre-Tipped Irrigator Syringe, 3cc, 30ga, Side Vented, Monoject Style, Sterile |
| D832INTSMPT03270 | Pre-Tipped Irrigator Syringe, 3cc, 27ga, Side Vented, Monoject Style, Sterile |
| D832INTSMPT03230 | Pre-Tipped Irrigator Syringe, 3cc, 23ga, Side Vented, Monoject Style, Sterile |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MONOVAC 79145819 4705827 Live/Registered |
Fondarex S.A. 2014-01-24 |
![]() MONOVAC 72312298 0874507 Dead/Expired |
INLAND STEEL COMPANY 1968-11-15 |