FDA Registration
Active
🇺🇸 United States
Titan Stabilizer Long Shaft Attachment
Reg #: 2953359
·
FEI: 3000215205
·
Expires 2025
Products
1
Proprietary Names
33
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S. LLC
- Registration Number
- 2953359
- FEI Number
- 3000215205
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2311 Lincoln Ave
- City
- Hayward
- State
- CA
- ZIP
- 94545
- 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 |
|---|---|---|---|---|---|
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2012-11-12 |
Proprietary Names
Titan Stabilizer Long Shaft Attachment
Titan Ultra Stabilizer Attachment
T401210S Assistant with StableSoft 3S
T401231LS Titan Stabilizer Long Shaft
T401211S Assistant with StableSoft 2L
T401261U Atlas 360 Positioner
JANKE-BARRON HEART SUPPORT
Titan Stabilizer
T401261 Atlas Positioner
T401245 StableSoft II Stabilizer - Long Shaft
T401212S Assistant with StableSoft 2S
T401244 StableSoft II Stabilizer
T401209S Assitant with StableSoft 3L
Atlas Positioner
T401231U Titan 360 Stabilizer
T401270 Suture Holder Insert
Atlas 360 Positioner Attachment
Atlas 360 Positioner Ultra
T401231 Titan Stabilizer
Titan 360 Stabilizer Attachment
Atlas Positioner Attachment
9945/25
9930/25
StableSoft II Stabilizer - Long Shaft
Suture Holder Insert
StableSoft II Stabilizer
Titan Stabilizer Attachment, Long Shaft
Atlas 360 Positioner
Titan Stabilizer - Long Shaft Attachment
Titan Flex 360 Stabilizer
Titan Flex Stabilizer
StableSoft Ultra Stabilizer
OPVAC Synergy Ultra
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)