FDA Registration
Active
🇺🇸 United States
STERIS Laboratories
Reg #: 2183828
·
FEI: 2183828
·
Expires 2026
Products
11
Proprietary Names
9
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- STERIS Laboratories
- Registration Number
- 2183828
- FEI Number
- 2183828
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9303 West Broadway Ave.
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- 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 |
|---|---|---|---|---|---|
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator | QWY | Class 3 | Unknown | No | 2023-10-13 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2012-12-28 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2014-03-03 |
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | Class 3 | Unknown | No | 2022-12-15 |
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator | QCZ | Class 3 | Unknown | No | 2019-11-01 |
| Apparatus, Hemoperfusion, Sorbent | FLD | Class 2 | Gastroenterology, Urology | No | 2018-01-09 |
| Embolization Agent, Vascular | QVG | Class 3 | Unknown | No | 2025-11-25 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2018-05-31 |
| Electrode, Corneal | HLZ | Class 2 | Ophthalmic | No | 2024-12-30 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2022-12-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-12-15 |
Proprietary Names
Avita6412 (NT,BP) - RECELL
BVI1689 (EP1) - Iris Ring
BVI1689 (EP1) - Iris Ring & Inserter
MicroSurg4751 (BP) - Malyugin RIng
VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small
VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System
Carbon5733 (BP) - Agent, Bulking, Injectable for Gastro-Urology Use
Avita6412 (BP,NT) - RECELL
DelcathSystems6324 (BP) - Delcath Dual Hemofiltration Cartridge
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only