FDA Registration
Active
🇺🇸 United States
TAPE, MEASURING, RULERS AND CALIPERS Glow N' Tell Tape
Reg #: 1319639
·
FEI: 1000138054
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1319639
- FEI Number
- 1000138054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 84 Park Rd
- City
- Queensbury
- State
- NY
- ZIP
- 12804
- Country
- US
Regulatory Submissions
- 510(k) Number
- K932184
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 |
|---|---|---|---|---|---|
| Assembly, Thigh/Knee/Shank/Ankle/Foot, External | KFX | Class 2 | Physical Medicine | No | 2012-11-16 |
Proprietary Names
TAPE, MEASURING, RULERS AND CALIPERS Glow N' Tell Tape
K932184
TAPE, MEASURING, RULERS AND CALIPERS Vascutape Radiopaque Marking Tape
Glow N' Tell Tape
Vascutape Radiopaque Marking Tape
LeMaitre Stent Guide
TAPE, MEASURING, RULERS AND CALIPERS LeMaitre Stent Guide
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)