Aesculap
DITTEL Urethral Bougie, curved, 13 1/2", (345 mm), diam. Charr. 12, stiff, non-sterile, reusable
1manufacturer
51catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | FAX |
| Device type | Bougie, Urological |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-20 |
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 |
|---|---|---|
| EF642R | In distribution | |
| EF643R | In distribution | |
| MG119R | In distribution | |
| MG116R | In distribution | |
| EF641R | In distribution | |
| EF830R | In distribution | |
| EF836R | In distribution | |
| EF848R | In distribution | |
| EF638R | In distribution | |
| MG114R | In distribution | |
| EF648R | In distribution | |
| EF649R | In distribution | |
| EF828R | In distribution | |
| EF844R | In distribution | |
| EF645R | In distribution | |
| MG117R | In distribution | |
| EF854R | In distribution | |
| MG111R | In distribution | |
| EF640R | In distribution | |
| EF650R | In distribution | |
| EF658R | In distribution | |
| EF824R | In distribution | |
| EF652R | In distribution | |
| EF846R | In distribution | |
| EF834R | In distribution | |
| EF840R | In distribution | |
| EF639R | In distribution | |
| EF856R | In distribution | |
| EF659R | In distribution | |
| MG112R | In distribution | |
| EF656R | In distribution | |
| EF647R | In distribution | |
| EF657R | In distribution | |
| MG115R | In distribution | |
| EF850R | In distribution | |
| EF660R | In distribution | |
| EF651R | In distribution | |
| MG118R | In distribution | |
| EF858R | In distribution | |
| EF832R | In distribution | |
| EF860R | In distribution | |
| MG113R | In distribution | |
| EF646R | In distribution | |
| EF826R | In distribution | |
| EF644R | In distribution | |
| EF852R | In distribution | |
| EF655R | In distribution | |
| EF842R | In distribution | |
| EF653R | In distribution | |
| EF654R | In distribution | |
| EF838R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 97 |
| 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 |
| 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.