Orascoptic – Spark TruColor Headlight System
10 catalogue numbers from 910133-22, listed by Metrex Research, United States, under Light, Surgical Headlight. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
10catalogue numbers in this listing
1recall
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 | Metrex Research, United States |
|---|---|
| FDA product code | EBA |
| Device type | Light, Surgical Headlight |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 910133-22 | In distribution | |
| 910133-31 | In distribution | |
| 910133-42 | In distribution | |
| 910133-1 | In distribution | |
| 910133-12 | In distribution | |
| 910133-2 | In distribution | |
| 910133-21 | In distribution | |
| 910133-11 | In distribution | |
| 910133-32 | In distribution | |
| 910133-41 | In distribution |
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 Headlight System | Metrex Research | 10 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 6 |
Showing 12 of 24. All products under Light, Surgical Headlight
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-11-17 | Class II | Labeling mix-ups | The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; howeve | 1330 units | 2012-11-20 |
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.