Gentlecath Glide
Gentlecath™ Glide Hydrophilic Intermittent Urinary Catheter With Water Sachet, Straight Tip, Female - Fr/Ch08
9manufacturers in China registered for this device type
16catalogue 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 |
| Record published | 2022-11-03 |
| Record revised | 2023-03-31 (version 14) |
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 30, case of 8, pack of 30, pack of 10 |
| Sizes | Catheter gauge 8 to 16 Fr |
| Distribution end date | 2023-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 421564 | Catheter Gauge 8.00000 Fr | In distribution |
| 421566 | Catheter Gauge 12.00000 Fr | In distribution |
| 421568 | Catheter Gauge 16.00000 Fr | In distribution |
| 421567 | In distribution | |
| 421570 | Catheter Gauge 8.00000 Fr | In distribution |
| 421565 | Catheter Gauge 10.00000 Fr | In distribution |
| 421564 | Withdrawn | |
| 421571 | Withdrawn | |
| 421570 | Withdrawn | |
| 421569 | Withdrawn | |
| 421566 | Withdrawn | |
| 421568 | Withdrawn | |
| 421573 | Withdrawn | |
| 421565 | Withdrawn | |
| 421574 | Withdrawn | |
| 421572 | 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
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.