Level ONE Transbuccal
Drill Guide, 2.0 MM, Tlts, Kansas, FOR 50-501-XX-07
1manufacturer
31catalogue 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 | 2024-08-27 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-476-05-07 | 42 MM | In distribution |
| 995-2950-01 | 58 MM | In distribution |
| 25-472-15-07 | 47 MM | In distribution |
| 25-479-15-07 | In distribution | |
| 50-501-30-07 | 31 MM | In distribution |
| 96-472-05-07 | 43 MM | In distribution |
| 25-471-00-07 | In distribution | |
| 995-7159-01 | In distribution | |
| 50-501-21-07 | 57 MM | In distribution |
| 99-572-44-01 | 57 MM | In distribution |
| 50-317-05-07 | In distribution | |
| 01-473-05-07 | 55 MM | In distribution |
| 01-473-15-07 | 67 MM | In distribution |
| 25-472-05-07 | 33 MM | In distribution |
| 50-501-31-07 | 57 MM | In distribution |
| 995-2950-02 | 71 MM | In distribution |
| 50-501-20-07 | 31 MM | In distribution |
| 01-100-97-07 | 70 MM | In distribution |
| 25-478-00-07 | 14 CM | In distribution |
| 50-090-15-07 | In distribution | |
| 50-501-35-07 | 31 MM | In distribution |
| 50-501-32-07 | 57 MM | In distribution |
| 25-472-00-07 | In distribution | |
| 25-478-15-07 | In distribution | |
| 50-501-43-07 | 31 MM | In distribution |
| 50-501-09-07 | 61 MM | In distribution |
| 96-472-15-07 | 57 MM | In distribution |
| 50-090-05-07 | 31 MM | In distribution |
| 01-473-20-07 | 55 MM | In distribution |
| 99-571-58-01 | 31 MM | In distribution |
| 01-476-15-07 | 45 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Level ONE | KLS-Martin L.P. | 6 |
| 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.