Guardus
The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
19manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (4), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Eternal (Shanghai) Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
Showing 12 of 19. All 19 manufacturers in China registered for Endoscopic Access Overtube, Gastroenterology-Urology
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K040836 |
| Record published | 2020-03-19 |
| Record revised | 2020-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 3, box of 3 |
| Sizes | Outer diameter 19.5 mm; lumen/inner diameter 16.7 to 17 mm; length 25 to 50 cm |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711147 | Outer Diameter 19.5 mm | In distribution |
| SI711147 | Lumen/Inner Diameter 17 mm | In distribution |
| SI711146 | Outer Diameter 19.5 mm | In distribution |
| 00711148 | Outer Diameter 19.5 mm | In distribution |
| 00711149 | Length 50 cm | In distribution |
| 00711146 | Outer Diameter 19.5 mm | In distribution |
| SI711149 | Outer Diameter 19.5 mm | In distribution |
| SI711148 | Outer Diameter 19.5 mm | In distribution |
| SI711148 | Lumen/Inner Diameter 17 mm | Withdrawn |
| SI711149 | Length 50 cm | Withdrawn |
| 00711148 | Lumen/Inner Diameter 16.7 mm | Withdrawn |
| SI711147 | Length 25 cm | Withdrawn |
| 00711147 | Lumen/Inner Diameter 17 mm | Withdrawn |
| 00711149 | Lumen/Inner Diameter 17 mm | Withdrawn |
| 00711146 | Length 25 cm | Withdrawn |
| SI711146 | Outer Diameter 19.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ClearPetra | Well Lead Medical Co., Ltd. | 175 |
| CoralWell | Macrolux Medical Technology Co., Ltd. | 56 |
| Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 35 |
| Single-use Ureteral Access Sheath | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 25 |
| Flexor | Cook Incorporated | 25 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 24 |
| Flexor Parallel | Cook Incorporated | 21 |
| Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 20 |
| Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 18 |
| Porges Coloplast | Coloplast A/S | 14 |
| Forté® AXP Access Sheath | Applied Medical Resources Corp. | 13 |
| Forté® HD Access Sheath | Applied Medical Resources Corp. | 13 |
Showing 12 of 66. All products under Endoscopic Access Overtube, Gastroenterology-Urology
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.