JosNoe Medical Inc
Dual Chamber Scope Warmer that Pre-Warms Multiple Laparoscopes.
7manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
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 | JosNoe Medical Inc, United States |
|---|---|
| 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 | 2019-11-05 |
| Record revised | 2019-09-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature from 28 °F |
| Packaging | Box of 10, box of 15, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JNM-200016 | In distribution | |
| JNM-LG01 | In distribution | |
| PS-500 | 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
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 |
|---|---|---|---|---|---|
| 2015-12-01 | Class II | Packaging process control | Damage to package seals potentially compromising sterility. | 1008 boxes | 2016-03-22 |
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.