FloShield/Plus
The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during…
The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
46manufacturers in China registered for this device type
32catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Comhuge Medical Wire AND Harness Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery
Record
| Listed by | Minimally Invasive Devices, LLC, United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2016-07-25 |
| Record revised | 2019-04-09 (version 3) |
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 15 to 115 °F |
| Packaging | Sales box of 6, salesbox of 6 |
| Sizes | Lumen/inner diameter 5 to 10 mm; outer diameter 8 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FSB-01-1045 | Outer Diameter 12 mm | In distribution |
| FSS-01-1030 | Outer Diameter 12 mm | In distribution |
| FSB-04-1000 | Outer Diameter 12 mm | In distribution |
| FTS1 | In distribution | |
| FSS-04-1000 | Outer Diameter 12 mm | In distribution |
| FSB-01-1000 | Outer Diameter 12 mm | In distribution |
| FSS-03-1045 | Outer Diameter 12 mm | In distribution |
| FSS-02-0500 | Outer Diameter 8 mm | In distribution |
| FSS-04-0500 | Outer Diameter 8 mm | In distribution |
| FSB-04-1030 | Outer Diameter 12 mm | In distribution |
| FSS-01-1045 | Outer Diameter 12 mm | In distribution |
| FSB-02-1000 | Outer Diameter 12 mm | In distribution |
| FSB-02-0530 | Outer Diameter 8 mm | In distribution |
| FSS-01-1000 | Outer Diameter 12 mm | In distribution |
| FSB-02-0545 | Outer Diameter 8 mm | In distribution |
| FSS-01-0545 | Outer Diameter 8 mm | In distribution |
| FSB-02-1045 | Outer Diameter 12 mm | In distribution |
| FSS-02-1030 | Lumen/Inner Diameter 10 mm | In distribution |
| FSS-02-0545 | Outer Diameter 8 mm | In distribution |
| FSS-04-0530 | Lumen/Inner Diameter 5 mm | In distribution |
| FSS-02-0530 | Outer Diameter 8 mm | In distribution |
| FSS-02-1000 | Outer Diameter 12 mm | In distribution |
| FSS-04-1045 | Outer Diameter 12 mm | In distribution |
| FSB-02-1030 | Outer Diameter 12 mm | In distribution |
| FSS-03-1030 | Outer Diameter 12 mm | In distribution |
| FSB-01-1030 | Outer Diameter 12 mm | In distribution |
| FSS-01-0500 | Outer Diameter 8 mm | In distribution |
| FSS-02-1045 | Outer Diameter 12 mm | In distribution |
| FSB-02-0500 | Outer Diameter 8 mm | In distribution |
| FSS-04-1030 | Outer Diameter 12 mm | In distribution |
| FSS-01-0530 | Outer Diameter 8 mm | In distribution |
| FSS-03-1000 | Outer Diameter 12 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 3,796 |
| Surgical Direct | Surgical Direct, Inc. | 2,319 |
| Novo Surgical | Novo Surgical, Inc. | 1,320 |
| Elmed Incorporated | Elmed, Inc. | 911 |
| Laparoscope, General & Plastic Surgery | Karl Storz GmbH & Co. KG | 774 |
| Snowden-Pencer | Steris Corporation | 693 |
| Millennium | Avalign Technologies, Inc. | 683 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 615 |
| Clickline | Karl Storz GmbH & Co. KG | 582 |
| V. Mueller | Carefusion 2200, Inc. | 553 |
| Grasping forceps | Sopro-Comeg GmbH | 462 |
| Gimmi | Gimmi Gmbh | 387 |
Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150705 | 2015-04-13 |
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.