Sephure® Suppository Applicator
B3 - rectal suppository applicator (individually wrapped)
2manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Cristcot LLC, United States |
|---|---|
| FDA product code | OOW |
| Device type | Applicator For Rectal Suppository |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K092829 |
| Record published | 2021-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B3-10 | 10 | In distribution | |
| B3 | In distribution | ||
| A2-10 | 10 | In distribution | |
| A2-30 | 30 | In distribution | |
| D0-6 | 6 | In distribution | |
| A2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synalax | Cristcot LLC | 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.