FDA Registration
Active
🇺🇸 United States
Kimball7603 (LN) - Curette 11G
Reg #: 1450662
·
FEI: 1450662
·
Expires 2025
Products
1
Proprietary Names
5
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 |
|---|---|---|---|---|---|
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2020-10-19 |
Proprietary Names
Kimball7603 (LN) - Curette 11G
StrykerPR3324 (VG) - iVAS Hand Drill
Ranfac3098 (NR) - Access Needle, Ranfac Bone Access Needle, Ranfac Access Needle
Ranfac3098 (NR) - Bone Access Needle
Kimball7603 (LN) - Curette 10G
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)