Kmedic
13 catalogue numbers from IPN015526, listed by Teleflex Medical LLC, United States, under Sound, Urethral, Metal Or Plastic. 1 manufacturer in China is registered for this product code.
1manufacturer
13catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Catheter gauge 10 to 34 Fr; length 29.2 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN015526 | Catheter Gauge 26 Fr | In distribution |
| IPN015528 | Catheter Gauge 30 Fr | In distribution |
| IPN015518 | Length 29.2 cm | In distribution |
| IPN015527 | Length 29.2 cm | In distribution |
| IPN015524 | Length 29.2 cm | In distribution |
| IPN015519 | Catheter Gauge 12 Fr | In distribution |
| IPN015521 | Length 29.2 cm | In distribution |
| IPN015520 | Catheter Gauge 14 Fr | In distribution |
| IPN015529 | Catheter Gauge 32 Fr | In distribution |
| IPN015523 | Catheter Gauge 20 Fr | In distribution |
| IPN015522 | Length 29.2 cm | In distribution |
| IPN015525 | Catheter Gauge 24 Fr | In distribution |
| IPN015530 | Catheter Gauge 34 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 204 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 165 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 105 |
| Hayden Medical | Hayden Medical Inc | 105 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 95 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 87 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 82 |
| V. Mueller | Steris Corporation | 73 |
| BR Surgical, LLC | BR Surgical LLC | 70 |
| Aesculap | Aesculap AG | 63 |
| HNM Medical | HNM Stainless, LLC. | 54 |
| Novo Surgical | Novo Surgical, Inc. | 45 |
Showing 12 of 33. All products under Sound, Urethral, Metal Or Plastic
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.