Gentlecath
Gentlecath™ Uncoated Intermittent Urinary Catheter, Straight Tip, Female - Fr/Ch14, 6.5"
9manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K010420 |
| Record published | 2016-09-09 |
| Record revised | 2024-12-16 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 100, case of 8, pack of 10, pack of 30, case of 100 |
| Sizes | Catheter gauge 8 to 18 Fr; length 16.5 to 17 cm |
| Distribution end date | 2022-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 501022 | Catheter Gauge 14 Fr | In distribution |
| 421909 | Catheter Gauge 12.00000 Fr | In distribution |
| 421908 | Catheter Gauge 10.00000 Fr | In distribution |
| 421912 | Catheter Gauge 18.00000 Fr | In distribution |
| 501019 | Catheter Gauge 8 Fr | In distribution |
| 501020 | CH10X6.5 IN | In distribution |
| 501021 | Catheter Gauge 12 Fr | In distribution |
| 501023 | CH16X6.5 IN | In distribution |
| 421911 | Catheter Gauge 16.00000 Fr | In distribution |
| 421438 | 14 FR | Withdrawn |
| 421435 | 16 FR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2022-09-20 | Class II | Nonconforming Material/Component | Product may not be sterile | 7200 catheters | |
| Teleflex Medical LLC | 510(k) number | 2016-11-22 | Class II | Error in labeling | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. | 102,843 units | 2017-11-24 |
| Teleflex Medical LLC | 510(k) number | 2005-07-11 | Not classified | Other | There is a lack of assurance of sterility for parts of these lots of product. | 95,800 units | 2007-11-14 |
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.