| Primary Device ID | 00854028002108 |
| NIH Device Record Key | afe00e4c-ff2a-4ccb-97bb-a2b783b9725a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trabectome Fluidics Set |
| Version Model Number | 550034-01 |
| Company DUNS | 945496792 |
| Company Name | NEOMEDIX CORPORATION |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854028002108 [Primary] |
| KYG | Device, Irrigation, Ocular Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-25 |
| Device Publish Date | 2019-07-17 |
| 10854028002136 - Trabectome High Frequency Generator (100-240V) | 2019-12-16 The Trabectome High Frequency Generator (100-240V) is used with compatible electrosurgical instruments for low power microsurgic |
| 10854028002167 - Trabectome I/A Console (100-240V) | 2019-12-16 The Trabectome I/A Console (100-240V) is an aspiration pump for use in general surgery applications where aspiration of irrigati |
| 00854028002023 - Trabectome I/A Console (110V) | 2019-12-16 The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irr |
| 00854028002030 - Trabectome High Frequency Generator (110V) | 2019-12-16 The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical instruments for low power microsurgical a |
| 00854028002092 - Trabectome Handpiece | 2019-12-16 The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic sur |
| 00854028002115 - Trabectome I/A Cannula | 2019-10-07 Customized Simcoe Type I/A Cannula with 20mm length straigh tip, 23GA x 23GA, Aspiration through a 13" flexible tubing via a 0.4 |
| 00854028002108 - Trabectome Fluidics Set | 2019-07-25Disposable, single use, surgical Irrigation and Aspiration tubing set |
| 00854028002108 - Trabectome Fluidics Set | 2019-07-25 Disposable, single use, surgical Irrigation and Aspiration tubing set |
| 00854028002177 - Goniotome +I/A Handpiece | 2019-07-25 The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plast |