FDA Registration
Active
🇺🇸 United States
Design2052 (NR) - CTS Relief Kit
Reg #: 2183744
·
FEI: 2183744
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2183744
- FEI Number
- 2183744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 380 90TH AVE NW
- City
- Minneapolis
- State
- MN
- ZIP
- 55433
- 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 |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
Proprietary Names
Design2052 (NR) - CTS Relief Kit
Etex2142 (NR) - Precision Cannula 150 mm
SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R
Hydrofera (NR, WH) - Instrument Wipe
Providien2420 (NT) - Z-Tray Hands Free Transfer Tray
PhoenixMed2991 (SP) - Instrument, manual, surgical, general use
Acuderm1463 (WH,LS) - Acu-Dispo-Ce
Providien2420 (NT) - Z-Suture Saddle Bag, 24 in.
Providien2420 (NT) -Stretch-A-Tray with Adhesive Strip
Providien2420 (NT) - Z-Cord Holder
Providien2420 (NT) - Z-Friction Drape Instrument Drape
Protech3048 (TM) - PHANTOM ML LIGHT CABLE
PhoenixMed2991 (SP) - Various Instruments
BeInnovative11045 (LN) - Rotolock Cord Management System
Providien2420 (NT) - Z-Suture Saddle Bag
Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Providien2420 (NT) - Z-Suture Saddle Bag, 20 in.
Abyrx4508 (WH) - Abyrx Putty Applicator
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)