FDA Registration
Active
🇺🇸 United States
StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX
Reg #: 1450662
·
FEI: 1450662
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1450662
- FEI Number
- 1450662
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1880 Industrial Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- 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 |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-27 |
Proprietary Names
StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX
Zimmer (LN,LS) - Bit, drill
Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM
Zimmer (LN,LS) - Maxfire
StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill
Zimmer (LN,LS) - Toggleloc
OrchidUnique5936 (LN) - Bit, Drill - Omega
Eagle1350 (NT,SN) - Drill
OmegaSurgical (LSRTC) - BIT, DRILL
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)