FDA Registration
Active
🇺🇸 United States
Providien2420 (NT) - Sandel Safety Marker; Time Out Marker
Reg #: 1319660
·
FEI: 1000136478
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1319660
- FEI Number
- 1000136478
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23 ELIZABETH DR.
- City
- CHESTER
- State
- NY
- ZIP
- 10918
- 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 |
|---|---|---|---|---|---|
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 1994-04-11 |
Proprietary Names
Providien2420 (NT) - Sandel Safety Marker; Time Out Marker
SteriPackUSA7760 (SP) - ClarifEye Markers
WolfX-Ray11781 (SP) - Steritatt
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)