FDA Registration
Active
🇺🇸 United States
DORC10527 (PL) - Vitrectomy System
Reg #: 2246552
·
FEI: 2246552
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2246552
- FEI Number
- 2246552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3459 SOUTH CLINTON AVE.
- City
- S Plainfield
- State
- NJ
- ZIP
- 07080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213467
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-02-19 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2025-02-19 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2025-02-19 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2025-02-19 |
Proprietary Names
DORC10527 (PL) - Vitrectomy System
DORC10527 (PL) - Phacoemulsification / Vitrectomy System
DORC10527 (PL) - Phacoemulsification / Vitrectomy System / Ophthalmic Laser
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)