FDA Registration
Active
🇺🇸 United States
OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Reg #: 2183744
·
FEI: 2183744
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2183744
- FEI Number
- 2183744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 380 90TH AVE NW
- City
- Minneapolis
- State
- MN
- ZIP
- 55433
- 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 |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
Proprietary Names
OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE
StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED
StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm
StrykerPR3324 (GR, LS, VG) - SJ Cutter
StrykerPR3324 (GR, LS, VG) - Irrig. Aggr.Mncs.
StrykerPR3324 (GR, LS, VG) - Pkg. ENT Irr. Agg. Sha
StrykerPR3324 (GR, LS, VG) - Cutter Full Radius
StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated
StrykerPR3324 (GR, LS, VG) - Cutter Meniscus
Zimmer (LN) - blade, saw, general and plastic surgery, surgical
StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM
StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs
StrykerPR3324 (GR, LS, VG) - Irr. Aggr. Shaver
StrykerPR3324 (GR, LS, VG) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED
StrykerPR3324 (GR, LS, VG) - Micdeb. Irrg./Agg.
StrykerPR3324 (GR, LS, VG) - 40 Deg. Ang. Agg. Shvbld.
StrykerPR3324 (GR, LS, VG) - Pkg, SharpEdge Shaver
StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm
StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade
OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite
StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade
StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)