Integra®
Integra® Miltex® LED Headlight w/Batteries & AC/DC Power Supply - US, Wide
1manufacturer
15catalogue 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 Production Corporation, United States |
|---|---|
| FDA product code | FSR |
| Device type | Light, Headband, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-09 |
| Record revised | 2023-04-17 (version 5) |
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 | Special storage condition: Do not expose the battery to temperatures higher than 49C (120 F) |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 90522 | 2 | In distribution | |
| 90520DUS | In distribution | ||
| 90530US | In distribution | ||
| 90520DWUS | In distribution | ||
| 90590US | In distribution | ||
| 90521 | In distribution | ||
| 90520US | In distribution | ||
| 90550US | In distribution | ||
| 90524 | In distribution | ||
| 90500W | In distribution | ||
| 90531 | In distribution | ||
| 90524US | In distribution | ||
| 90520WUS | In distribution | ||
| 90523 | In distribution | ||
| 90500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 18 |
| Integra® Duo | Integra Lifesciences (Ireland) Limited | 14 |
| 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.