Porges Coloplast
RETRACE® Ureteral Access Sheath, inner diameter CH FR 12, outer diameter CH FR 14, length 28 cm
19manufacturers in China registered for this device type
14catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Coloplast A/S, Denmark |
|---|---|
| FDA product code | FED |
| Device type | Endoscopic Access Overtube, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-08-01 |
| Record revised | 2024-08-30 (version 4) |
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 | Special storage condition: Store away from light in a cool and dry place |
| Sizes | Catheter gauge 10 to 14 Fr |
| Distribution end date | 2024-07-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASXL12 | Catheter Gauge 12 Fr | In distribution |
| AXXL12 | Catheter Gauge 14 Fr | In distribution |
| ALXL10 | Catheter Gauge 12 Fr | In distribution |
| ACXL12 | Catheter Gauge 14 Fr | In distribution |
| AXXL10 | Catheter Gauge 10 Fr | In distribution |
| ALXL12 | Catheter Gauge 12 Fr | In distribution |
| ASXL10 | Catheter Gauge 10 Fr | In distribution |
| ACXL10 | Catheter Gauge 10 Fr | In distribution |
| AXXS12 | Catheter Gauge 14 Fr | Withdrawn |
| AXXS10 | Catheter Gauge 12 Fr | Withdrawn |
| AXXL12 | Catheter Gauge 12 Fr | Withdrawn |
| ACXS12 | Catheter Gauge 12 Fr | Withdrawn |
| ACXS10 | Catheter Gauge 10 Fr | Withdrawn |
| ACXL12 | Catheter Gauge 14 Fr | 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 |
| Guardus | Us Endoscopy | 16 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181811 | 2018-09-07 |
| K140523 | 2014-07-24 |
| K123675 | 2013-03-01 |
| K102485 | 2010-10-18 |
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.