Jedmed
Trocar Antrum Coakley Light Curve
1manufacturer
4catalogue 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 | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | KBG |
| Device type | Trocar, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 53-2903 | In distribution | |
| 53-2529 | In distribution | |
| 53-2505 | In distribution | |
| 53-2904 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Level ONE Transbuccal | KLS-Martin L.P. | 31 |
| Level ONE | KLS-Martin L.P. | 6 |
| 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.