FDA Registration
Active
🇺🇸 United States
Merit1383 (TM) - Mak-NV
Reg #: 1220477
·
FEI: 1220477
·
Expires 2025
Products
1
Proprietary Names
27
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 |
|---|---|---|---|---|---|
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
Proprietary Names
Merit1383 (TM) - Mak-NV
PFMMedical6614 (TM) - Scripps 5F x 10cm Jet-Vac Procedure Trays (Ref: M7854SC)
PFMMedical6614 (TM) - Eisenhower 5F x 10cm Jet-Vac Procedure Tray (Ref M7854EI)
Ranfac3098 (NR) - GIU-30, 31G-END, 30G-END, GIU-31
PFMMedical6614 (TM) - 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613211)
PFMMedical6614 (TM) - Palomar 5F x 7cm Jet-Vac Procedure Trays (Ref M7853P)
PFMMedical6614 (TM) - 4F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613210)
PFMMedical6614 (TM) - 5F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613213)
PFMMedical6614 (TM) - 5F x 15cm Jet-Vac Centesis Catheter (Ref M7515)
PFMMedical6614 (TM) - 4F x 7cm Jet-Vac Centesis Catheter (Ref M7511)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Procedure Tray (Ref M7852)
Ranfac3098 (NR) - Sialography Unit Endport
PFMMedical6614 (TM) - 5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613214)
PFMMedical6614 (TM) - Palomar 5F x 10cm Jet-Vac Procedure Trays (Ref M7854P)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Centesis Catheter (Ref M7513)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Procedure Tray (Ref M7853)
PFMMedical6614 (TM) - Eisenhower 5F x 7cm Jet-Vac Procedure Tray (Ref M7853EI)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Centesis Catheter (Ref M7512)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Centesis Catheter (Ref M7514)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Safety Procedure Tray (Ref M7553)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref 850007)
Merit1383(TM) - Introducer Needle with Trocar Stylet, NAK-NV Non-Vascular
PFMMedical6614 (TM) - 5F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613212)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554NM)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref M7854)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Safety Procedure Tray (Ref M7552)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)