V. Mueller
Otis Bougie A Boule 38FR Olive TIP
1manufacturer
17catalogue 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 | Steris Corporation, United States |
|---|---|
| FDA product code | FAX |
| Device type | Bougie, Urological |
| 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 | 2018-08-30 |
| Record revised | 2024-08-19 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GU4005-038 | In distribution | |
| GU4005-024 | In distribution | |
| GU4005-036 | In distribution | |
| GU4005-034 | In distribution | |
| GU4005-010 | In distribution | |
| GU4005-030 | In distribution | |
| GU4005-022 | In distribution | |
| GU4005-028 | In distribution | |
| GU4005-032 | In distribution | |
| GU4005-026 | In distribution | |
| GU4005-008 | In distribution | |
| GU4005-018 | In distribution | |
| GU4005-016 | In distribution | |
| GU4005-020 | In distribution | |
| GU4005-040 | In distribution | |
| GU4005-014 | In distribution | |
| GU4005-012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 97 |
| Aesculap | Aesculap AG | 51 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 31 |
| Sklar | Sklar Corporation | 18 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 17 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 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.