Rusch
SUPRAFLEX SUPRAPUBIC 2 WAY 5-10ml ALL SILICONE CATHETER, STERILE PACK
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K952187 |
| Record published | 2015-10-16 |
| Record revised | 2025-08-22 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Keep dry |
| Packaging | Case of 10, box of 5, carton of 10, box of 2, case of 40 |
| Sizes | Length 206 to 510 mm; outer diameter 3.3 to 5.3 mm; lumen/inner diameter 4 mm; width 30 mm; height 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN050001 | Length 206 mm | In distribution |
| IPN044966 | In distribution | |
| IPN050003 | Lumen/Inner Diameter 4 mm | In distribution |
| IPN050002 | Outer Diameter 5.3 mm | In distribution |
| IPN050000 | Length 206 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniSPC Button | Applied Medical Technology, Inc. | 284 |
| Malecot | Cook Incorporated | 39 |
| Cook | Cook Incorporated | 35 |
| Stamey | Cook Incorporated | 16 |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | Fortune Medical Instrument Corp. | 10 |
| Rutner | Cook Incorporated | 9 |
| Silicone Supra-Pubic Catheter (Integrated Balloon) | Fortune Medical Instrument Corp. | 8 |
| Cook-Cope Loop | Cook Incorporated | 8 |
| Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) | Fortune Medical Instrument Corp. | 7 |
| S-Cath™ | Mediplus Ltd. | 7 |
| Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) | Fortune Medical Instrument Corp. | 7 |
| Mediplus | Mediplus Ltd. | 6 |
Showing 12 of 23. All products under Catheter, Suprapubic (And Accessories)
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.