FDA Registration
Active
🇺🇸 United States
REUSABLE X-LONG 20D BUR TIP
Reg #: 1058584
·
FEI: 1000219637
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1058584
- FEI Number
- 1000219637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10811 Withers Cove Park Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- Country
- US
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2012-10-29 |
Proprietary Names
REUSABLE X-LONG 20D BUR TIP
MICROCHOICE R EX 70&90 IRR TIP
ST ULTRAPOWER BUR ACORN 9/MDS R-1 UltraPower
REUS IRRIG HANDPIECE CLIP
ST ULTRAPOWER BUR ACORN 6/MDS R-3 UltraPower
REUSABLE Y IRRIGATION TUBING
Pericardiocentesis Catheter Kit Safety Paracentesis Tray
Safety Paracentesis Tray
ReSolve Locking Drainage Catheter
ReSolve Non-Locking Drainge Catheter
One-Step Centesis Catheter
Catheter, Irrigation (Infiltration Tubing)
Total Abscession General Drainage Catheters
4203/25
4312/24
17912/10
4302
4316/24
4313/24
17912/25
Cen-Step Centesis Catheter
Chest Tube Insertion Kit
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)