| Primary Device ID | 00861578000379 |
| NIH Device Record Key | 009c29d0-35e6-411c-9a2b-72c20d9c3ff3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | mi-eye Procedure Kit |
| Version Model Number | T900-001 |
| Company DUNS | 009452895 |
| Company Name | TRICE MEDICAL, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 610-989-8080 |
| customercare@tricemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861578000379 [Primary] |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-11-10 |
| 00857356008026 - mi-eye 2 | 2023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN |
| 00857356008118 - mi-eye 2 | 2023-11-17 TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM |
| 00857356008224 - mi-tablet 3 | 2023-11-17 mi-tablet 3 |
| 00857356008231 - mi-eye 3 | 2023-11-17 mi-eye 3 needlescope, 95mm |
| 00857356008248 - mi-eye 3 | 2023-11-17 mi-eye 3 angled scope, 120mm |
| 00857356008255 - mi-eye 3 | 2023-11-17 mi-eye 3 25 deg scope, 75mm with cannula |
| 00857356008262 - mi-eye 3 | 2023-11-17 mi-eye 3 scope, 95mm with cannula |
| 00857356008279 - mi-eye 3 | 2023-11-17 mi-eye 3 25° scope, 75mm with cannula |