FDA Registration
Active
🇺🇸 United States
SP SAPH3 M LIGHT PANEL
Reg #: 1061124
·
FEI: 1000512168
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1061124
- FEI Number
- 1000512168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10821 Withers Cove Park Dr
- 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 |
|---|---|---|---|---|---|
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2018-01-11 |
Proprietary Names
SP SAPH3 M LIGHT PANEL
SP SAPH3 SS LIGHT PANEL
SAPH III L LIGHT PANEL
Light Handle Cover
Medichoice Light Handle Cvr Light Handle Cover 60511 1/pk 160/case Sterile
Light Guard Rigid 2/pkg Sterile - (40 packs of 2)
Medichoice Light Handle Cover (80 Packs of 2). Light Handle: 60512
Medichoice Light Handle Cover Light Handle Cover 60513 3/pk 64 pk/case Sterile
Lyte Guardian
Medichoice Rigid Handle (40 Packs of 2). Light Handle Rigid: 60882
Light Handle Cover 1/pkg
Light Guard Rigid 1/pkg Sterile
Medichoice Rigid Handle Rigid Light Handle 60881 1 ea 64/case
Light Handle Cover 3/pkg
Light Handle Cover 2/pkg
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)