| 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 | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| Phone | 610-989-8080 |
| customercare@tricemedical.com | |
| 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 |
| 00857356008767 - Tenex 2nd Generation MicroTip, TXL, 3.0 WL | 2025-03-14 |
| 00857356008774 - Tenex 2nd Generation MicroTip, TXL+, 2.5 WL | 2025-03-14 |
| 00857356008781 - Tenex 2nd Generation MicroTip, TXS, 2.0 WL | 2025-03-14 |
| 00857356008798 - Tenex 2nd Generation MicroTip, TXS+, 1.3 WL | 2025-03-14 |
| 00857356008842 - Tenex 2nd Generation Console | 2025-03-14 |
| 00857356008859 - Tenex 2nd Generation Fuse Set | 2025-03-14 |
| 10861578000376 - mi-eye Procedure Kit 5 pack | 2025-03-03 pack of 5 T900-001 |
| 00857356008026 - mi-eye 2 | 2023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN |