Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle
Catalogue number SL291, listed by Sterilucent, Inc., United States, under Indicator, Biological Sterilization Process. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Sterilucent, Inc., United States |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Record published | 2020-04-29 |
| Record revised | 2025-09-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 60 to 100 % RH; Storage environment temperature 36 to 77 °F; Special storage condition: Do not store in direct sunlight or any other form of UV light.; Special storage condition: • Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volati |
| Distribution end date | 2021-12-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SL291 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionova® | Terragene S.A. | 47 |
| Attest™ | 3M Company | 36 |
| Verify | Steris Corporation | 27 |
| 3M™ Attest™ | 3M Company | 16 |
| Celerity | Steris Corporation | 15 |
| Biotrace™ | Terragene S.A. | 11 |
| Single Species BI Strip | Crosstex International | 11 |
| Tuttnauer® | Terragene S.A. | 10 |
| Sterrad Velocity™ | Advanced Sterilization Products Services Inc. | 8 |
| GPS | Group Practice Solutions | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Propper Duo Spore Biological Indicators | Propper Manufacturing Co., Inc. | 7 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192001 | 2019-10-22 |
| K141238 | 2014-11-03 |
| K141312 | 2014-10-31 |
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.