Gyrus Acmi, Inc
Repl Lamp FOR Entire 150 Illuminator.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Taizhou Huangyan Guanhong Plastic Steel Products Factory | Taizhou | Zhejiang | Contract manufacturer | 16 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EBA |
| Device type | Light, Surgical Headlight |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2024-09-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2020-10-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70231057 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spark™ TruColor™ | Metrex Research | 42 |
| zumax | Zumax Medical Co., Ltd. | 42 |
| Light, Surgical Headlight | Black & Black Surgical, Inc. | 40 |
| Endeavour™ TruColor™ XL | Metrex Research | 28 |
| Endeavour™ TruColor™ | Metrex Research | 28 |
| Endeavour™ MD | Metrex Research | 22 |
| Orascoptic – Endeavour XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour Headlight System | Metrex Research | 18 |
| Orascoptic – Spark TruColor Headlight System | Metrex Research | 10 |
| Orascoptic – Spark Headlight System | Metrex Research | 10 |
Showing 12 of 24. All products under Light, Surgical Headlight
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.