Span-America
903350-0 Atlas 36/53x80 w/FS
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Hainan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Cnooc Yonglian Pharmaceutical Innovation (Hainan) Co., Ltd. | Qionghai | Hainan | Manufacturer | 1 |
Record
| Listed by | Span-America Medical Systems, Inc., United States |
|---|---|
| FDA product code | KIY |
| Device type | Chamber, Slide Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Atlas | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mdhc | Mdhc Life Technologies (Kunshan) Co., Ltd. | 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.