Fujifilm
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical…
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
Who Else Makes It
Concentrated in Zhejiang (3), Anhui (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Suzhou SMH Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Hunan Handlike Minimally Invasive Surgery Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | NWV |
| Device type | Laparoscopic Accessories, Gynecologic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-04 |
| Record revised | 2024-10-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-01B | In distribution | |
| CB-01P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 201 |
| AED | National Advanced Endoscopy Devices, Inc. | 173 |
| Elmed | Elmed, Inc. | 36 |
| Elite | National Advanced Endoscopy Devices, Inc. | 8 |
| Elmed Incorporated | Elmed, Inc. | 7 |
| AbGrab | Lapovations, LLC | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Laparoscopic Accessories, Gynecologic | Stryker Sustainability Solutions | 5 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5 |
| TroClear | Mednium Corporation | 5 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| Eco Fit | National Advanced Endoscopy Devices, Inc. | 4 |
Showing 12 of 80. All products under Laparoscopic Accessories, Gynecologic
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.