FDA Registration
Active
🇺🇸 United States
Non woven dressing Advadraw
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
34
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029275
- FEI Number
- 1000306431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 344 Bonnie Cir
- City
- Corona
- State
- CA
- ZIP
- 92878
- 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 |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
Proprietary Names
Non woven dressing Advadraw
Foam/silicone Advazorb Silfix/Silfix Lite
Foam/silicone Advazorb Silflo/Silflo Lite
Woven Eclypse
Super absorbent woven Eclypse Adherent Sacral
Super absorbent woven dressing Eclypse Boot
Dressing, Wound Hydrophilie
Triad
Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085
Advazorb Border Lite
Zorflex ZF10
Zorflex ZF15
Advadraw Spiral
Advazorb Border
Zetuvit (plus)
Eclypse Foot
Advazorb Heel
Eclypse Adherent Sacral
Advazorb Sacral
Zorflex ZF20
Advadraw
Advazorb Fixation
Eclypse Adherent
Eclypse Boot
Advazorb
Eclypse Border & Border Oval
Eclypse Contour
Advazorb Areola
Eclypse
Zetuvit Plus Silicone (Border)
Advazorb Silfix
Non woven ribbon dressing Advadraw Spiral
Woven Ecylpse Adherent
Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)