TruCath
TruCath Intermittent Catheter 16FR 16" Male Hydrophilic Soft with Water Sachet and Touchless Sleeve
11manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (6), Jiangsu (4), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 3 |
| Xianju JF Medister Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | HR Pharmaceuticals Inc. |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K111405 |
| Record published | 2020-02-20 |
| Record revised | 2024-03-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 30, case of 10, case of 30, pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC1416 | In distribution | |
| HS1216 | In distribution | |
| CC1416 | In distribution | |
| HC0810 | In distribution | |
| SC1616S | In distribution | |
| HS0810 | In distribution | |
| SC1416S | In distribution | |
| SC1006 | In distribution | |
| SC1816 | In distribution | |
| HS1006 | In distribution | |
| HC1216S | In distribution | |
| SC0810 | In distribution | |
| HS1216S | In distribution | |
| SC1406NC | In distribution | |
| SC1016 | In distribution | |
| HS1010 | In distribution | |
| SC0610 | In distribution | |
| SC0816 | In distribution | |
| SC1216 | In distribution | |
| HS1606 | In distribution | |
| HC1010 | In distribution | |
| CC1816 | In distribution | |
| HC1416S | In distribution | |
| CC1216 | In distribution | |
| HS1206 | In distribution | |
| SC1216S | In distribution | |
| HS1616S | In distribution | |
| SC1616 | In distribution | |
| HC1616S | In distribution | |
| SC1606 | In distribution | |
| HS1616 | In distribution | |
| SC0806 | In distribution | |
| SC1406 | In distribution | |
| HS1816 | In distribution | |
| HS1416 | In distribution | |
| HC1416 | In distribution | |
| CC1016 | In distribution | |
| HC1216 | In distribution | |
| CC0810 | In distribution | |
| SC1010 | In distribution | |
| CC1616 | In distribution | |
| HC1016 | In distribution | |
| HS1406 | In distribution | |
| SC1206 | In distribution | |
| HS1416S | In distribution | |
| HC1616 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| SpeediCath Standard | Coloplast A/S | 47 |
| VaPro | Hollister Incorporated | 31 |
| Actreen® | B. Braun Medical Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 25 |
| BD Intermittent | Hangzhou Bever Medical Devices Co., Ltd. | 24 |
| Gentlecath AIR | Convatec, Purchasing Department | 24 |
| VaPro Pocket | Hollister Incorporated | 23 |
| Apogee | Hollister Incorporated | 23 |
| Dover | Cardinal Health | 23 |
| Dover | Cardinal Health 200, LLC | 22 |
| Teleflex | Teleflex Medical LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
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.