Sklar
Otis Bougie A Boule SET/13
1manufacturer
18catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | FAX |
| Device type | Bougie, Urological |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85-1635 | In distribution | |
| 85-1612 | In distribution | |
| 85-1620 | In distribution | |
| 85-1638 | In distribution | |
| 85-1624 | In distribution | |
| 85-1637 | In distribution | |
| 85-1610 | In distribution | |
| 85-1616 | In distribution | |
| 85-1618 | In distribution | |
| 85-1634 | In distribution | |
| 85-1630 | In distribution | |
| 85-1640 | In distribution | |
| 85-1636 | In distribution | |
| 85-1632 | In distribution | |
| 85-1626 | In distribution | |
| 85-1614 | In distribution | |
| 85-1622 | In distribution | |
| 85-1628 | 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 |
| 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.