Sigma Virocult
Sigma Virocult, 1 x Mini Foam 78mm BP & 1 x Std Foam 79mm BP
3manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Medical Wire & Equipment Company (Bath), Ltd., United Kingdom |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| 510(k) | K082472 |
| Record published | 2023-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution | |
| N/a | 125 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 21 |
| Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 14 |
| Puritan UniTranz-RT | Puritan Medical Products Company LLC | 13 |
| Sigma Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 11 |
| Starswab II Bacteriology Culture Collection and Transport System | Pretium Canada Packaging ULC | 10 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Bacti-Swab | Remel, Inc. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Puritan | Puritan Medical Products Company LLC | 4 |
| Covidien | Cardinal Health 200, LLC | 3 |
| Puritan Opti-Swab | Puritan Medical Products Company LLC | 3 |
| Caplugs/Evergreen | Caplugs, Inc. | 2 |
Showing 12 of 35. All products under Device, Specimen Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103805 | 2011-01-25 |
| K082472 | 2008-12-30 |
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.