FDA Registration
Active
🇺🇸 United States
TRU-FIX Catheter Fixation Kit
Reg #: 3004111573
·
FEI: 3004111573
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 3004111573
- FEI Number
- 3004111573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1302 Avenue T
- City
- Grand Prairie
- State
- TX
- ZIP
- 75050
- 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 |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-12 |
Proprietary Names
TRU-FIX Catheter Fixation Kit
Bandages
KA2310W/25
MTS003/100
KA2130/50
KA1224/50
KA2211/25
KA1154/25
Zip DS Dressing Shield
KA2254/25
KA1118/50
KA1124/25
KA2154/50
KA2210/25
Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001
KA2210/50
KA1254/25
KA1124/100
OPSITE Post Op, IV 3000
KA2110/50
OPSITE, IV3000 Frame Delivery
TrialOn
OPSITE, IV3000 1-Hand
OPSITE Flexigrid, IV3000 Standard
OPSITE Flexigrid, IV3000 Ported
Breg
COVRSITE Plus
OPSITE, IV3000 1-Hand Ported
BAND-AID® Brand TOUGH STRIPS® Bandages
Tube Holder 100/case
Tube Holder White
Incise Film
Skin Fix
BAND-AID® Brand Flexible Fabric Bandages
Dressings (Breg)
SureSeal Pressure Bandage
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)