FDA Registration
Active
🇺🇸 United States
Temporary Sharps Holder "ShortStopGrandstand
Reg #: 1526534
·
FEI: 1526534
·
Expires 2025
Products
1
Proprietary Names
46
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US, LLC
- Registration Number
- 1526534
- FEI Number
- 1526534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305 Enterprise Dr
- City
- Lewis Center
- State
- OH
- ZIP
- 43035
- 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 |
|---|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-01 |
Proprietary Names
Temporary Sharps Holder "ShortStopGrandstand
11 guage Bone Access Needles
OnPharma OnSet Cartridge Connector
Homer Breast Localization Needles
MiniStop Plus
BackStop Plus
Disposable Needles
Monoject Bone Marrow Biopsy Tray with Safety Components
MEDTRONIC Facet Screw Instruments
CHI1915
CHI2320
CHI1820
CHI2220
CHI229
FNA - Fine Needle Aspiration
CHI2120
Turkel Safety Fluid Drainage System
CHI2015
CHI2210
PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810, N815
CHI2010
CHI2020
Curity Amniocentesis Tray
CHI2215
Curity Thoracentesis Trays with Safety Components
CHI1815
CHIBA NEEDLE
BONE BIOPSY NEEDLE
CHI1920
CHI205
CHI226
CHI2115
Facet Screw Instruments
CHI2315
Turkel Thoracentesis System: 566034
Turkel Thoracentesis System: 566059
Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed
Anesthesia Peribulbar; Retrobulbar Needles
Turkel Thoracentesis System: 566075
Monoject Bone Marrow Biopsy and Aspiration Tray with Safety Components
Monoject Bone Marrow Biopsy / Aspiration Needle
Monoject Bone Marrow Biopsy Prepping Tray with Safety Components
Monoject Sternal-lliac Aspiration Needle
Turkel Safety Thoracentesis Procedural Tray
Monoject Basic Bone Marrow Biopsy Tray with Safety Components
Monoject Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)