Level ONE
6 catalogue numbers from 96-472-48-07, listed by KLS-Martin L.P., United States, under Trocar, Sinus. 1 manufacturer in China is registered for this product code.
1manufacturer
6catalogue numbers in this listing
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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | KBG |
| Device type | Trocar, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2021-04-21 (version 4) |
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 |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96-472-48-07 | Withdrawn | |
| 96-472-64-07 | Withdrawn | |
| 99-577-45-01 | Withdrawn | |
| 99-571-60-01 | Withdrawn | |
| 99-559-62-02 | Withdrawn | |
| 50-092-15-07 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Level ONE Transbuccal | KLS-Martin L.P. | 31 |
| Jedmed | Jedmed Instrument Company | 4 |
| Trocar | KLS-Martin L.P. | 1 |
| V. Mueller | Carefusion 2200, Inc. | 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.