FDA Registration
Active
🇺🇸 United States
PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540)
Reg #: 1220477
·
FEI: 1220477
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1220477
- FEI Number
- 1220477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 435 WHITNEY ST.
- City
- Northboro
- State
- MA
- ZIP
- 01532
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2013-01-28 |
Proprietary Names
PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540)
PFMMedical6614 (TM) - 4.5F x 5cm Micro Introducer Kit (Ref M450540)
PFMMedical6614 (TM) - 6.5F x 7cm Micro Introducer Kit (Ref M650740)
PFMMedical6614 (TM) - 3.5F x 7cm Micro Introducer Kit (Ref M350740)
PFMMedical6614 (TM) - 4.5F x 7cm Micro Introducer Kit (Ref M450740)
PFMMedical6614 (TM) - 5.5F x 7cm Micro Introducer Kit (Ref M550740)
PFMMedical6614 (TM) - 5.5F x 5cm Micro Introducer Kit (Ref M550540)
PFMMedical6614 (TM) - 3.5F x 5cm Micro Introducer Kit (Ref M350540)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)