FDA Registration
Active
🇧🇪 Belgium
PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 9MM 2/CA Portex Griggs Percutaneous Blu Line Tra
Reg #: 3005941719
·
FEI: 3002807111
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Belgium Petit Rechain S.A.
- Registration Number
- 3005941719
- FEI Number
- 3002807111
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21
- City
- Verviers Liege
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K060945
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 |
|---|---|---|---|---|---|
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2012-11-20 |
Proprietary Names
PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 9MM 2/CA Portex Griggs Percutaneous Blu Line Tra
PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 8MM 2/CA Portex Griggs Percutaneous Blu Line Tra
PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 7MM 2/CA Portex Griggs Percutaneous Blu Line Trac
PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 7MM 2/CA Portex Griggs Percutaneous Blu Line Tra
PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 9MM 2/CA Portex Griggs Percutaneous Blu Line Trac
PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 8MM 2/CA Portex Griggs Percutaneous Blu Line Trac
K060945
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)