| Primary Device ID | 00850440008346 |
| NIH Device Record Key | 4f2ac584-2fda-42aa-907d-3cf9b59d9507 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IrriGator |
| Version Model Number | ESIT3026 |
| Company DUNS | 079892178 |
| Company Name | Engineered Endodontics, LLC |
| 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 | true |
| Lot Batch | true |
| 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 |
|---|---|
| GS1 | 00850440008346 [Primary] |
| EIC | Syringe, Periodontic, Endodontic, Irrigating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2026-01-02 |
| 00850440008384 | Irrigation tip 30 gauge |
| 00850440008377 | Irrigation tip 27 gauge |
| 00850440008360 | Irrigation tip 30 gauge |
| 00850440008353 | Irrigation Tip 27 gauge |
| 00850440008346 | Irrigation tip 30 gauge 26mm long |
| 00850440008339 | Irrigation Tip 30 gauge 22mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IRRIGATOR 75838576 3074997 Live/Registered |
Florida Irrigation Supply, Inc. 1999-11-03 |
![]() IRRIGATOR 75424286 2253088 Dead/Cancelled |
World Class Studios, Inc. 1998-01-27 |
![]() IRRIGATOR 74501200 2074584 Dead/Cancelled |
PLASTIC SPECIALTIES AND TECHNOLOGIES, INC. 1994-03-14 |
![]() IRRIGATOR 74357333 1861486 Dead/Cancelled |
POWERMARK LTD. 1993-02-09 |
![]() IRRIGATOR 72446068 0978601 Dead/Expired |
DART INDUSTRIES INC. 1973-01-15 |
![]() IRRIGATOR 72417214 0946179 Dead/Expired |
UNIVERSAL OIL PRODUCTS COMPANY 1972-03-02 |