FDA Registration
Active
🇺🇸 United States
SPINAL NEEDLE 25GX90MM T.W. + 10/CA Portex Spinal Anesthesia Trays
Reg #: 1721686
·
FEI: 1721686
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1721686
- FEI Number
- 1721686
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2400 Airport Rd
- City
- Santa Teresa
- State
- NM
- ZIP
- 88008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983858
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, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2012-11-21 |
Proprietary Names
SPINAL NEEDLE 25GX90MM T.W. + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 27GX3.5" PP + 10/CA Portex Spinal Anesthesia Trays
K983858
SPINAL NEEDLE 22GX3.5" LP + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 22GX2.5" LP + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 25GX3" LP + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 25GX3.5" LP + 10/CA Portex Spinal Anesthesia Trays
Single use, sterile procedural tray/kit
SPINAL NEEDLE 20GX1.5" LP + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 22GX3.5" PP + 10/CA Portex Spinal Anesthesia Trays
SPINAL NEEDLE 27GX3.5" LP + 10/CA Portex Spinal Anesthesia Trays
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)