SPY-PHI System
SPY-PHI Articulating Arm, Imaging Head Holder
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
Record
| Listed by | Axcess Surgical Innovations, LLC |
|---|---|
| FDA product code | FXR |
| Device type | Holder, Camera, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Premarket notification | Exempt |
| Record published | 2019-08-29 |
| Record revised | 2026-06-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HH1003 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet Equipment | Maquet Gmbh | 83 |
| Holder, Camera, Surgical | Maquet Gmbh | 8 |
| SHA Outer ring | Pixee Medical | 1 |
| Life Instruments | Life Instrument Corp. | 1 |
| Conmed | ConMed Corporation | 1 |
| SPY-PHI System | Tedan Surgical Innovations, L.L.C. | 1 |
| Fluoclip | Fluoptics SAS | 1 |
| Arthrex® | Arthrex, Inc. | 1 |
| Jedmed | Jedmed Instrument Company | 1 |
| SHA Connector | Pixee Medical | 1 |
| miniARM® multiSTATION™ System | LSI Solutions Inc. | 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.