Integra® Duo
Integra® Duo Duo 4 Bay Power Kit with Two Batteries, Charger, Power Supply, Charger Cord & Holster - US
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Jiangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Integra Lifesciences (Ireland) Limited, Ireland |
|---|---|
| FDA product code | FSR |
| Device type | Light, Headband, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-11-14 |
| Record revised | 2025-02-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 80 % RH; Storage environment temperature -20 to 49 °C; Handling environment atmospheric pressure 500 to 1060 millibar; Storage environment atmospheric pressure 500 to 1060 millibar; Handling environment humidity 30 to 80 % RH; Handling environment temperature -20 to 49 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 90660US | In distribution | ||
| 90664US | In distribution | ||
| 90640US | In distribution | ||
| 90620CS | In distribution | ||
| 90634US | In distribution | ||
| 90621 | In distribution | ||
| 90622 | 2 | In distribution | |
| 90670 | In distribution | ||
| 90690US | In distribution | ||
| 90600 | In distribution | ||
| 90624US | In distribution | ||
| 90630US | In distribution | ||
| 90642 | 10 | In distribution | |
| 90620US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 18 |
| Integra® | Integra LifeSciences Production Corporation | 15 |
| Integra® | Integra Lifesciences (Ireland) Limited | 3 |
| Light, Headband, Surgical | Karl Storz GmbH & Co. KG | 2 |
| Brasseler EZX | Imedicom Co., Ltd. | 1 |
| Light, Headband, Surgical | National Advanced Endoscopy Devices, 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.