FDA Registration
Active
🇺🇸 United States
Smith&Nephew3754 (NR) - 4.5 Incisor Plus
Reg #: 1220477
·
FEI: 1220477
·
Expires 2025
Products
1
Proprietary Names
122
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1220477
- FEI Number
- 1220477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 435 WHITNEY ST.
- City
- Northboro
- State
- MA
- ZIP
- 01532
- 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 |
|---|---|---|---|---|---|
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2018-04-27 |
Proprietary Names
Smith&Nephew3754 (NR) - 4.5 Incisor Plus
Smith&Nephew3754 (NR) - 4.5 Synovator, Curved Concave
Smith&Nephew3754 (NR) - 5.5 mm Elite Acromionizer
Smith&Nephew3754 (NR) - 5.5 AcromioBlaster
Smith&Nephew3754 (NR) - 2.9 Abrader, Mini
Smith&Nephew3754 (NR) - 4 mm Elite AcromioBlaster
Smith&Nephew3754 (NR) - 4.5mm Synovator PLATINUM
Smith&Nephew3754 (NR) - 2.9 Barrel Abrader, Mini
Smith&Nephew3754 (NR) - 4 NotchBlaster
Smith&Nephew3754 (NR) - 4.5 BoneCutter Full Radius
Smith&Nephew3754 (NR) - 4.5 Synovator, Orbit
Smith&Nephew3754 (NR) - 4.5 Incisor
Smith&Nephew3754 (NR) - 4 mm Elite Notchblaster
Smith&Nephew3754 (NR) - 3.5 RazorCut, Mini
Smith&Nephew3754 (NR) - 5.5 Full Radius Elite
Smith&Nephew3754 (NR) - 4.5 Full Radius, 180mm lg.
Smith&Nephew3754 (NR) - 4.5 Incisor, Orbit
Smith&Nephew3754 (NR) - 4.5 Full Radius, Orbit, Ultra Series
Smith&Nephew3754 (NR) - 4 Short Sheath
Smith&Nephew3754 (NR) - 5.5 RazorCut
Smith&Nephew3754 (NR) - 4.5 Full Radius Elite
Smith&Nephew3754 (NR) - 5.5mm Barrel Abrader High Visibility, 180mm
Smith&Nephew3754 (NR) - 4.5 Incisor Plus, Curved Concave
Smith&Nephew3754 (NR) - 4.5 Full Radius, Curved Convex, 180mm lg.
Smith&Nephew3754 (NR) - Flat Top High Visibility Burr 4mm x 180mm
Smith&Nephew3754 (NR) - 5.5 StoneCutter
Smith&Nephew3754 (NR) - 5.5 BoneCutter Synovator
Smith&Nephew3754 (NR) - 3.5 Incisor
Smith&Nephew3754 (NR) - 4 mm Abrader, 180 mm
Smith&Nephew3754 (NR) - 4.5 Incisor Plus, Orbit
Smith&Nephew3754 (NR) - 2 Full Radius Mini Blade
Smith&Nephew3754 (NR) - 3.5 Incisor, Mini, 8cm lg.
Smith&Nephew3754 (NR) - 5.5 mm Elite Stonecutter
Smith&Nephew3754 (NR) - 4.5 Full Radius, Orbit
Smith&Nephew3754 (NR) - 3.5 mm Full Radius Curved Concave
Smith&Nephew3754 (NR) - 5.5 Incisor
Smith&Nephew3754 (NR) - Flat Top High Visibility Burr 5.5mm x 180mm
Smith&Nephew3754 (NR) - 3.5mm PLATINUM Incisor Plus
Smith&Nephew3754 (NR) - 5.5 Full Radius, 180mm lg.
Smith&Nephew3754 (NR) - 4.5 Incisor, Orbit, Ultra Series
Smith&Nephew3754 (NR) - 4 StoneCutter
Smith&Nephew3754 (NR) - 5.5 Elite Notchblaster
Smith&Nephew3754 (NR) - 2.9 Incisor, Mini
Smith&Nephew3754 (NR) - 4.5 Full Radius, Curved Concave
Smith&Nephew3754 (NR) - 5.5 Synovator/Incisor, Inner
Smith&Nephew3754 (NR) - 5.5 Synovator
Smith&Nephew3754 (NR) - 4.5 Turbowhisker, Curved Concave
Smith&Nephew3754 (NR) - 5.5 mm Abrader, 180 mm
Smith&Nephew3754 (NR) - 4.5 RazorCut, Orbit
Smith&Nephew3754 (NR) - 3.5 Incisor Plus, Mini, 8cm lg.
Smith&Nephew3754 (NR) - 4.5 Incisor Plus Platinum
Smith&Nephew3754 (NR) - DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE
Smith&Nephew3754 (NR) - 4.5 mm Incisor Plus Elite, Curved, 180 mm
Smith&Nephew3754 (NR) - 5.5 Short Sheath
Smith&Nephew3754 (NR) - 5.5 BoneCutter Full Radius
Smith&Nephew3754 (NR) - 4.5 Incisor Plus, Orbit, Ultra Series
Smith&Nephew3754 (NR) - 3.5 Full Radius, Mini, 8cm lg.
Smith&Nephew3754 (NR) - 4.5 Synovator
Smith&Nephew3754 (NR) - 4.5mm PLATINUM Incisor Plus Curved
Smith&Nephew3754 (NR) - 5.5 mm Elite AcromioBlaster
Smith&Nephew3754 (NR) - 3.5 Incisor, Mini
Smith&Nephew3754 (NR) - 5.5mm High Visibility Abrader, 180mm
Smith&Nephew3754 (NR) - 4.5 Incisor, 180mm lg.
Smith&Nephew3754 (NR) - 4.5 mm Incisor Plus Elite, 180 mm long
Smith&Nephew3754 (NR) - 4.5mm PLATINUM Synovator Curved
Smith&Nephew3754 (NR) - 3.5 Cutter
Smith&Nephew3754 (NR) - 4.5mm Bonecutter PLATINUM
Smith&Nephew3754 (NR) - 4 Abrader
Smith&Nephew3754 (NR) - 5.5mm Synovator PLATINUM
Smith&Nephew3754 (NR) - 5.5mm Full Radius PLATINUM
Smith&Nephew3754 (NR) - 5.5 mm Incisor Plus Elite
Smith&Nephew3754 (NR) - 5.5mm Incisor Plus PLATINUM
Smith&Nephew3754 (NR) - 4mm PLATINUM FLYER
Smith&Nephew3754 (NR) - 2.9 Full Radius Mini Blade
Smith&Nephew3754 (NR) - 4 mm Elite Stonecutter
Smith&Nephew3754 (NR) - 4.5 mm Full Radius Elite Curved
Smith&Nephew3754 (NR) - 4.5 RazorCut
Smith&Nephew3754 (NR) - 3.5 Abrader, Mini
Smith&Nephew3754 (NR) - 4 mm Elite Acromionizer
Smith&Nephew3754 (NR) - 4.5 Incisor, Curved Concave
Smith&Nephew3754 (NR) - 5.5 Abrader
Smith&Nephew3754 (NR) - 5.5 mm Elite Abrader
Smith&Nephew3754 (NR) - 4.5 mm Incisor Plus Elite Curved
Smith&Nephew3754 (NR) - 4.5 RazorCut, Orbit, Ultra Series
Smith&Nephew3754 (NR) - 5.5 Full Radius
Smith&Nephew3754 (NR) - DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE
Smith&Nephew3754 (NR) - 5.5 Acromionizer
Smith&Nephew3754 (NR) - 4.5 Sharp Incisor Plus
Smith&Nephew3754 (NR) - 3.5 mm Full Radius Elite
Smith&Nephew3754 (NR) - 4.5 Helicut Blade
Smith&Nephew3754 (NR) - 4.5 Full Radius
Smith&Nephew3754 (NR) - 3.5mm PLATINUM Synovator
Smith&Nephew3754 (NR) - 3.5 Incisor, Mini, Curved Concave, 8cm lg.
Smith&Nephew3754 (NR) - 4 Acromionizer
Smith&Nephew3754 (NR) - DYONICS 5.5 MM ELITE STONECUTTER STRAIGHT DISPOSABLE BURRS, OLIVE, 10000 MAXIMUM RPM, PACKAGED
Smith&Nephew3754 (NR) - 2 Incisor, Mini
Smith&Nephew3754 (NR) - 4.5 mm Full Radius Elite Orbit
Smith&Nephew3754 (NR) - 3.5 mm Incisor Plus Elite
Smith&Nephew3754 (NR) - 4 mm Elite Abrader
Smith&Nephew3754 (NR) - 4.5 TurboTrimmer
Smith&Nephew3754 (NR) - 4mm Barrel Abrader High Visibility, 180mm
Smith&Nephew3754 (NR) - 3.5 RazorCut
Smith&Nephew3754 (NR) - 4.5 Cutter
Smith&Nephew3754 (NR) - 4.5 mm Incisor Plus Elite
Smith&Nephew3754 (NR) - 5.5mm Bonecutter PLATINUM
Smith&Nephew3754 (NR) - 3.5 BoneCutter, Full Radius
Smith&Nephew3754 (NR) - 5.5 NotchBlaster
Smith&Nephew3754 (NR) - 4.5 Synovator Outer with Full Radius Inner
Smith&Nephew3754 (NR) - 4.5 BoneCutter Synovator
Smith&Nephew3754 (NR) - 4.5mm Full Radius PLATINUM
Smith&Nephew3754 (NR) - BLADE 3.5 BONE CUTTER FULL RADIUS DISP
Smith&Nephew3754 (NR) - 4 AcromioBlaster
Smith&Nephew3754 (NR) - 4.5 Full Radius, Curved Concave, 180mm lg.
Smith&Nephew3754 (NR) - 4.5 Bonecutter, 180mm Lg.
Smith&Nephew3754 (NR) - 4.5 Synovator, Orbit, Ultra Series
Smith&Nephew3754 (NR) - 3.5mm PLATINUM Bonecutter
Smith&Nephew3754 (NR) - 3.5 Full Radius
Smith&Nephew3754 (NR) - DYONICS 3.5 MM FULL RADIUS BLADES, 7 CM LENGTH, PLUM, PACKAGED 6 PER BOX, STERILE
Smith&Nephew3754 (NR)- 4mm High Visibility Abrader, 180mm
Smith&Nephew3754 (NR) - 4.5 TurboWhisker
Smith&Nephew3754 (NR) - 5.5 Incisor Plus
Smith&Nephew3754 (NR) - 3.5 RazorCut, Mini, 8cm lg.
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)