Bard® McCrea Model Female Urethral Sound
Bard Metal (McCrea Model) Female Sound Stainless Steel 32 Fr.
1manufacturer
15catalogue 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 | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-01-18 |
| Record revised | 2020-02-06 (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 |
| Sizes | Catheter gauge 8 to 36 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 604232 | Catheter Gauge 32 Fr | In distribution |
| 604236 | Catheter Gauge 36 Fr | In distribution |
| 604220 | Catheter Gauge 20 Fr | In distribution |
| 604224 | Catheter Gauge 24 Fr | In distribution |
| 604230 | Catheter Gauge 30 Fr | In distribution |
| 604228 | Catheter Gauge 28 Fr | In distribution |
| 604216 | Catheter Gauge 16 Fr | In distribution |
| 604218 | Catheter Gauge 18 Fr | In distribution |
| 604222 | Catheter Gauge 22 Fr | In distribution |
| 604226 | Catheter Gauge 26 Fr | In distribution |
| 604234 | Catheter Gauge 34 Fr | In distribution |
| 604208 | Catheter Gauge 8 Fr | In distribution |
| 604210 | Catheter Gauge 10 Fr | In distribution |
| 604212 | Catheter Gauge 12 Fr | In distribution |
| 604214 | Catheter Gauge 14 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.