Primus Sterilizer
Steam Sterilizer, Healthcare, G1
3manufacturers in China registered for this device type
24catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Primus Sterilizer Company, LLC., United States |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Manufacturer |
| 510(k) | K093333 |
| Record published | 2019-03-05 |
| Record revised | 2023-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS5-A-M | In distribution | |
| PSS8-E-M | In distribution | |
| PSS8-C-M | In distribution | |
| PSS5-G-M | In distribution | |
| PSS8-B-M | In distribution | |
| PSS5-F-M | In distribution | |
| PSS5-D-M | In distribution | |
| PSS8-F-M | In distribution | |
| PSS5-K-M | In distribution | |
| PSS8-K-M | In distribution | |
| PSS8-A-M | In distribution | |
| PSS5-G1-M | In distribution | |
| PSS8-J-M | In distribution | |
| PSS5-J-M | In distribution | |
| PSS8-G-M | In distribution | |
| PSS5-AA-M | In distribution | |
| PSS8-G1-M | In distribution | |
| PSS5-M-M | In distribution | |
| PSS5-B-M | In distribution | |
| PSS5-E-M | In distribution | |
| PSS8-D-M | In distribution | |
| PSS5-C-M | In distribution | |
| PSS8-M-M | In distribution | |
| PSS8-AA-M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
| Bravo 21V Autoclave | Scican Ltd. | 17 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233132 | 2023-12-19 |
| K221474 | 2023-02-10 |
| K093333 | 2010-04-02 |
| K082817 | 2009-05-21 |
| K991575 | 1999-12-03 |
| K926185 | 1994-05-09 |
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.