FDA Registration
Active
🇺🇸 United States
Tyber6592 (WH,CH1) - Tyber Medical 5.5 HCS; Tyber Medical 6 HCS; Tyber Medical 6.5 HCS; Tyber Medical 7 HCS;
Reg #: 2245304
·
FEI: 2245304
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 2245304
- FEI Number
- 2245304
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Apollo Dr
- City
- WHIPPANY
- State
- NJ
- ZIP
- 07981
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153575
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-10-27 |
Proprietary Names
Tyber6592 (WH,CH1) - Tyber Medical 5.5 HCS; Tyber Medical 6 HCS; Tyber Medical 6.5 HCS; Tyber Medical 7 HCS;
Tyber6592 (WH, CH1) - Tyber Medical 3.5 HCS; Tyber Medical 4 HCS; Tyber Medical 4.5 HCS; Tyber Medical 5 HCS
Tyber6592 (WH,CH1) - Tyber Medical 1.5 HCS; Tyber Medical 2 HCS; Tyber Medical 2.5 HCS; Tyber Medical 3 HCS
Tyber6592 (WH,CH1) - Tyber Medical 8 HCS; Tyber Medical 9 HCS
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)