FDA Registration
Active
🇬🇧 United Kingdom
VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF)
Reg #: 8021896
·
FEI: 3001168737
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ALBERT BROWNE LTD.
- Registration Number
- 8021896
- FEI Number
- 3001168737
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rayns Way, Watermead Business Park Syston
- City
- LEICESTER
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K162758
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-10-09 |
Proprietary Names
VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Long (PCC033) (LC-CFE)
VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD)
VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD)
VERIFY SixCess 270F Flash Indicator (LCC310) (LC-MF)
VERIFY SixCess 270F 4 Minute Indicator - Long (PCC008) (LC-MF)
VERIFY SixCess 270F 15 Minute Indicator (PCC031) (LC-MF)
VERIFY SixCess 250F 30 Minute Indicator - Long (PCC007) (LC-MF)
VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD)
VERIFY SixCess 270F 4 Minute Indicator - Short (PCC006) (LC-MF)
VERIFY SixCess 275F Flash Indicator (LCC005) (LC-CFE)
VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-SD)
VERIFY Bowie Dick Test Pack (EQC010) (HP-CFE)
VERIFY SixCess 275F 3 Minute Indicator - Short (PCC038) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Short (PCC037) (LC-MF)
VERIFY SixCess 275F 3 Minute Indicator - Long (PCC034) (LC-MF)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198