Greenwald Surgical Company, Inc.
Friedman-Otis Bougie-a-Boule, with 3 (graduated) olive tips on one stem. Mirror finish, stainless steel, precision machined.
1manufacturer
31catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
Record
| Listed by | Grace Manufacturing Inc, United States |
|---|---|
| FDA product code | FAX |
| Device type | Bougie, Urological |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-31 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Liquid Chemical |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Catheter gauge 8 to 40 Fr; length 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52020-34 | Catheter Gauge 34 Fr | In distribution |
| 51900-28 | Catheter Gauge 28 Fr | In distribution |
| 51900-24 | Catheter Gauge 24 Fr | In distribution |
| C0001-08 | Length 10 cm | In distribution |
| 51900-36 | Catheter Gauge 36 Fr | In distribution |
| 52020-16 | Catheter Gauge 16 Fr | In distribution |
| 51900-14 | Catheter Gauge 14 Fr | In distribution |
| 51900-38 | Catheter Gauge 38 Fr | In distribution |
| 52022-28 | Catheter Gauge 20 Fr | In distribution |
| 51900-20 | Catheter Gauge 20 Fr | In distribution |
| 52022-36 | Catheter Gauge 36 Fr | In distribution |
| C0001-018 | Catheter Gauge 18 Fr | In distribution |
| 51900-12 | Catheter Gauge 12 Fr | In distribution |
| 52020-28 | Catheter Gauge 28 Fr | In distribution |
| 51900-22 | Catheter Gauge 22 Fr | In distribution |
| 51900-40 | Catheter Gauge 40 Fr | In distribution |
| 51900-26 | Catheter Gauge 26 Fr | In distribution |
| 51900-32 | Catheter Gauge 32 Fr | In distribution |
| 52020-22 | Catheter Gauge 22 Fr | In distribution |
| 51900-34 | Catheter Gauge 34 Fr | In distribution |
| C0001-014 | Catheter Gauge 14 Fr | In distribution |
| 51900-10 | Catheter Gauge 10 Fr | In distribution |
| 51900-08 | Catheter Gauge 8 Fr | In distribution |
| C0001-012 | Length 10 cm | In distribution |
| 52022-20 | Catheter Gauge 20 Fr | In distribution |
| C0001-010 | Catheter Gauge 10 Fr | In distribution |
| 51900-18 | Catheter Gauge 18 Fr | In distribution |
| C0001-016 | Length 10 cm | In distribution |
| 51900-30 | Catheter Gauge 30 Fr | In distribution |
| 51900-16 | Catheter Gauge 16 Fr | In distribution |
| 52020-40 | Catheter Gauge 40 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 97 |
| Aesculap | Aesculap AG | 51 |
| Sklar | Sklar Corporation | 18 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 17 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 17 |
| V. Mueller | Steris Corporation | 17 |
| Novo Surgical | Novo Surgical, Inc. | 13 |
| Surgipros | Surgipros LLC | 12 |
| Van Buren Bougies | RZ Medizintechnik Gmbh | 1 |
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.