FDA Registration Active 🇺🇸 United States

Protech3048 (TM) - Vein Pick

Reg #: 2030624 · FEI: 3000206435 · Expires 2025
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
2

Registration Details

Registration Name
Isomedix Operations, Inc.
Registration Number
2030624
FEI Number
3000206435
Status
Active
Expiry Year
2025
Initial Importer
No
Address
43425 Business Park Dr
City
Temecula
State
CA
ZIP
92590
Country
US

Regulatory Submissions

PMA Number
P030054

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
Implantable Cardioverter Defibrillator (Non-Crt) LWS
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX

Proprietary Names

Protech3048 (TM) - Vein Pick Protech3048 (TM) - Slit Suture Sleeve

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)