FDA Registration
Active
🇺🇸 United States
CleanStart
Reg #: 1825014
·
FEI: 1825014
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Skytron, LLC
- Registration Number
- 1825014
- FEI Number
- 1825014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5085 Corporate Exchange Blvd SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Owner / Operator
- Firm Name
- Skytron, LLC
- Operator Number
- 9918015
- Address
- 5085 Corporate Exchange Blvd SE, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Robert - Vreeland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2015-12-09 |
Proprietary Names
CleanStart
Skytron I3; Skytron I5; Sterling Washer P1500, P1000, P1800
Flex Surgical Instrument Washer
C2000LW-E208
C2000LW-S208
C2000-S480
C2000W-S480
C2000L-S208
C2000-E208
C2000-S208
C2000W-E480
C2000L-E208
C2000L-E480
C2000LW-E480
C2000W-E208
C2000W-S208
C2000L-S480
C2000LW-S480
Sterling C2000 Series Cart Washer
C2000-E480
UV Smart D25 (& Trolley)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility