Obtura Spartan
S-Kondenser, 50-100 (Yellow)
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Young Innovations Inc., United States |
|---|---|
| FDA product code | EKG |
| Device type | Condenser, Amalgam And Foil, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-06 |
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, manufacturing date |
| Packaging | Package of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 825-202 | In distribution | |
| 825-204 | In distribution | |
| 825-203 | In distribution | |
| 825-201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 199 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 107 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 50 |
| Pomee | Pomee Corporation | 44 |
| Aesculap | Aesculap AG | 21 |
| Zoll-Dental | Zoll-Dental | 17 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 12 |
| Kohdent | Kohler Medizintechnik GmbH | 12 |
| Ergoplant | Aesculap AG | 10 |
| Quinelato | Schobell Industrial Ltda | 9 |
| Osung MND | Osung MND Co., Ltd. | 9 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 9 |
Showing 12 of 51. All products under Condenser, Amalgam And Foil, Operative
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.