Salman FES Stent
2 catalogue numbers from SS2000, listed by Boston Medical Products, Inc., United States, under Cannula, Sinus. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Boston Medical Products, Inc., United States |
|---|---|
| FDA product code | KAM |
| Device type | Cannula, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K922902 |
| Record published | 2015-09-20 |
| Record revised | 2022-08-30 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SS2000 | In distribution | |
| SS2000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 46 |
| Frazier suction tube | Spiggle & Theis Medizintechnik Gmbh | 28 |
| Bear | Bear-ENT, LLC | 25 |
| Eicken antrum cannula | Spiggle & Theis Medizintechnik Gmbh | 19 |
| Medline | Medline Industries, Inc. | 17 |
| Jedmed | Jedmed Instrument Company | 11 |
| Osseous Suction tubes for Nose Reusable | EON Meditech PVT. Ltd. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Relieva Flex | Acclarent, Inc. | 8 |
| Instrumentarium | Société Chirurgicale Instrumentarium Inc | 7 |
| Integra® | Integra LifeSciences Production Corporation | 6 |
| Inka | The Trustee for Kaiser Family Trust | 4 |
Showing 12 of 59. All products under Cannula, Sinus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922902 | 1993-05-18 |
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.