Navina Inserts
Starter Pack of 5 individually packaged Navina Inserts consisting of 3 regular size and 2 large size single shot Inserts
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Renew Group Private Limited, Singapore |
|---|---|
| FDA product code | PBP |
| Device type | Rectal Insert |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122003 |
| Record published | 2019-01-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 69302 | 30 | In distribution | |
| 69303 | 30 | In distribution | |
| 69301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StaySure | Minnesota Medical Technologies | 6 |
| Renew Inserts | Renew Group Private Limited | 6 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122003 | 2012-10-26 |
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.