FDA Registration
Active
🇺🇸 United States
6F GREEN INPUT 23 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 2011171
- FEI Number
- 2011171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4900 Gifford Ave
- City
- Los Angeles
- State
- CA
- ZIP
- 90058
- Country
- US
Regulatory Submissions
- 510(k) Number
- K980973
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 |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2012-12-05 |
Proprietary Names
6F GREEN INPUT 23 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER
6F PF CHOICE PK ST XT KIT MEDTRONIC ANGIOGRAPHIC CATHETER
6F PF ST ARI MEDTRONIC ANGIOGRAPHIC CATHETER
6F PF ST JR3.5 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
6F 23CM INPUT INTRO. KIT MEDTRONIC ANGIOGRAPHIC CATHETER
6F PF ST JR6 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
5F SS MP B-1 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
8F BLUE INPUT 11 DILATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER
7F 23CM OBTURATOR ASSEMBLY MEDTRONIC ANGIOGRAPHIC CATHETER
6F 11 CM ENHANCED INPUT TS CATHETER MEDTRONIC ANGIOGRAPHIC CATHETER
6F 23CM ENHANCED INPUT TS MEDTRONIC ANGIOGRAPHIC CATHETER
7F EI TS 23CM OBTURATOR ASSY MEDTRONIC ANGIOGRAPHIC CATHETER
INPUT 2 26CM STER SLEV W/OCCL MEDTRONIC ANGIOGRAPHIC CATHETER
6F 23CM ENHANCED INSERTION MEDTRONIC ANGIOGRAPHIC CATHETER
7F 23CM ENHANCED INSERTION MEDTRONIC ANGIOGRAPHIC CATHETER
4F SS CHAMP 0.5 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
7F PF XT 110 PIGTAIL MEDTRONIC ANGIOGRAPHIC CATHETER
6F SS SONES C 80CM MEDTRONIC ANGIOGRAPHIC CATHETER
5F GREY INPUT 11 ASSY MEDTRONIC ANGIOGRAPHIC CATHETER
8F ADULT TRANSEPTAL HEMAQUET SHEATH ASSEMBLY TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
6F SS AR 1 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
6F SS NTR 100CM MEDTRONIC ANGIOGRAPHIC CATHETER
5F 11CM INPUT INTROD MEDTRONIC ANGIOGRAPHIC CATHETER
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)