TRAB(TM)360 Trabeculotomy System
US version of the TRAB360
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Sight Sciences, Inc., United States |
|---|---|
| FDA product code | HMZ |
| Device type | Trabeculotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-11-23 |
| Record revised | 2023-08-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 03706 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Duckworth & Kent | Duckworth AND Kent Limited | 3 |
| Sion Surgical Instrument | Sight Sciences, Inc. | 1 |
| Omni(R) Surgical System (US) | Sight Sciences, Inc. | 1 |
| Omni Surgical System (US) | Sight Sciences, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.