Aurora Hydrocolloide Adhesive Sheath
Aurora Condomcatheter Met Hydrocolloide Kleefzone
13manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
Showing 12 of 13. All 13 manufacturers in China registered for Device, Incontinence, Urosheath Type, Non-Sterile
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | NNX |
| Device type | Device, Incontinence, Urosheath Type, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 30, case of 360, case of 180 |
| Sizes | Outer diameter 25 to 41 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW305 | Outer Diameter 41 mm | In distribution |
| SW302 | Outer Diameter 29 mm | In distribution |
| SU304 | Outer Diameter 36 mm | In distribution |
| SU303 | Outer Diameter 32 mm | In distribution |
| SW301 | Outer Diameter 25 mm | In distribution |
| SP302 | Outer Diameter 29 mm | In distribution |
| SP301 | Outer Diameter 25 mm | In distribution |
| SU301 | Outer Diameter 25 mm | In distribution |
| SP304 | Outer Diameter 36 mm | In distribution |
| SU302 | Outer Diameter 29 mm | In distribution |
| SU305 | Outer Diameter 41 mm | In distribution |
| SW303 | Outer Diameter 32 mm | In distribution |
| SP305 | Outer Diameter 41 mm | In distribution |
| SP303 | Outer Diameter 32 mm | In distribution |
| SW304 | Outer Diameter 36 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clear Advantage Male Continence Sheath | C.R. Bard, Inc. | 40 |
| Spirit® Hydrocolloid Adhesive Sheath | C.R. Bard, Inc. | 30 |
| Transfix Continence Sheath | C.R. Bard, Inc. | 15 |
| Freedom Clear | Coloplast A/S | 14 |
| UltraFlex™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Freedom Clear Advantage | Coloplast A/S | 10 |
| InView Extra | Hollister Incorporated | 10 |
| Wideband™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Clear Advantage Spirit Adhesive Sheath | C.R. Bard, Inc. | 10 |
| Pop-On™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| InView Standard | Hollister Incorporated | 10 |
| InView Special | Hollister Incorporated | 10 |
Showing 12 of 86. All products under Device, Incontinence, Urosheath Type, Non-Sterile
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.