FDA Registration Active 🇺🇸 United States

3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE

Reg #: 3007366790 · FEI: 3007282753 · Expires 2025
Products
1
Proprietary Names
130
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Smith & Nephew, Inc.
Registration Number
3007366790
FEI Number
3007282753
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
3303 E Holmes Rd
City
Memphis
State
TN
ZIP
38118
Country
US

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

Products

Device Name Product Code
Saw, Powered, And Accessories HAB

Proprietary Names

3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE MTO,4.5MM TURBOCUTTER II,(6/BX) INLINE DRILL BIT 2.7 MM, SUITABLE FOR USE WITH BIORAPTOR 2.9 MM ANCHORS FOR SOFT BONE PowerMax Elite, hand control; Power moter drive DRILL 5.5MM SPADE TIP HIGH VISIBILITY SHEATH 5.5 MM FLAT TOP BURR 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE 4.5MM FULL RADIUS PLATINUM SERIES DYONICS SAGITTAL SAW W/KEY SML BAT HNDPC INCISOR PLUS ELITE LONG 4.5MM 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL 4.5MM SYNOVATOR PLATINUM SERIES 4.5 mm Synovator Platinum Curved Blade 4.5 mm Incisor Plus Platinum Curved Blade 4mm PLATINUM FLYER Blade 3.5 mm Bonecutter Platinum Blade Platinum Handpiece DYONICS MINI-MOTOR DRIVE, SUCTION LEVER, 10 FT 3 M CORD 5.5 MM FULL RADIUS STRAIGHT BLADE DYONICS 2.9 MM TURBOWHISKER BLADES, 7 CM LENGTH, GREEN, PACKAGED 6 PER BOX, STERILE 3.5 MM INCISOR STRAIGHT BLADE DYONICS 2.9 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, PEACH, PACKAGED 6 PER BOX, STERILE MOTOR DRIVE UNIT NON-HAND CNTL PWRMX BLADE 4 ELITE ABRADER 6/BX 5.5 MM SYNOVATOR STRAIGHT BLADE DYONICS 3.5 MM FULL RADIUS BLADES, 7 CM LENGTH, PLUM, PACKAGED 6 PER BOX, STERILE DYONICS 4MM ELITE ACROMIOBLASTER BURR 4.5 MM SYNOVATOR STRAIGHT BLADE POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, HAND CONTROLS, SUCTION LEVER, 10 FEET 3 M CORD. DYONICS 5.5MM ELITE ACROMIONIZER BURR BURR 5.5MM ABRADER 180MML DISPOSABLE 3.5 MM CUTTER STRAIGHT BLADE 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE HIGH VISIBILITY SHEATH 5.5 MM BARREL BURR BLADE 3.5MM ELITE FULL RADIUS 4.5 MM ORBIT SYNOVATOR CURVED BLADE 5.5 MM RAZORCUT STRAIGHT BLADE DYONICS 4MM ELITE NOTCHBLSTR ABRD BURR DYONICS 5.5 FULL RADIUS BONECUTTER BLADES, ORANGE, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE FULL RADIUS BONECUTTER 4.5MM PLATINUM HIGH VISIBILITY SHEATH 4 MM ABRADER BURR DYONICS 5.5MM ELITE STONECUTTER BURR 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE 4 MM STONECUTTER STRAIGHT BURR 5.5 MM STONECUTTER STRAIGHT BURR 4 MM ACROMIONIZER STRAIGHT BURR DYONICS POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD. DYONICS 3.5 MM RAZORCUT BLADES, 7 CM LENGTH, PUMPKIN ORANGE, PACKAGED 6 PER BOX, STERILE 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE 5.5MM SYNOVATOR PLATINUM SERIES 3.5 MM RAZORCUT STRAIGHT BLADE DYONICS 5.5MM ELITE NOTCHBLSTR ABRD BURR DYONICS 2.9 MM CUTTER BLADES, 7 CM LENGTH, BEIGE, PACKAGED 6 PER BOX, STERILE MOTOR DRIVE UNIT HAND CNTRL PWRMX EL Saw, powered FULL RADIUS BONECUTTER 5.5MM PLATINUM 5.5 MM INCISOR STRAIGHT BLADE DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE HIGH VISIBILITY SHEATH 4 MM BARREL BURR 3.5MM SYNOVATOR PLAT BLD 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE DYONICS POWER CABLE ASSEMBLY 5.5MM FULL RADIUS PLATINUM SERIES 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE 4.5 MM TURBOTRIMMER STRAIGHT BLADE DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE 4 MM ABRADER STRAIGHT BURR Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster DYONICS 2 MM TURBOWHISKER BLADES, 7 CM LENGTH, YELLOW, PACKAGED 6 PER BOX, STERILE 4.5 MM ORBIT INCISOR CURVED BLADE MTO BLADE SYNOVATOR/INCISOR 4.5 DSPL DYO 4.5 MM INCISOR STRAIGHT BLADE DYONICS 3.5 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, SAGE GREEN, PACKAGED 6 PER BOX, STERILE DYONICS 5.5MM ELITE ACROMIOBLASTER BURR MTO 5.5 MM FULL RADIUS SHAVER BLADES, 18 CM DYONICS 4MM ELITE ACROMIONIZER BURR(6) DYONICS 5.5MM ELITE ABRADER BURR 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE HIGH VISIBILITY SHEATH 4 MM FLAT TOP BURR 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE 4.5MM INCISOR PLUS PLATINUM BLADE DISPOSABLE BL 4.5MM CURVED FR ELITE (6) INCISOR PLUS ELITE BLADE 3.5MM DSPL DYO 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE DYONICS KEYLESS SAGITTAL SW SML BT HNDPC CURVED LONG INCISOR PLUS ELITE BLADE 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE 4.5 MM FULL RADIUS STRAIGHT BLADE BLADE,4.5 BONECUTTER,FR,180MM LG,DSP 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX 3.5 MM FULL RADIUS BLADE BLADE 5.5 FULL RADIUS ELITE DISPOSABLE 4.5 MM RAZORCUT STRAIGHT BLADE DYONICS 2.9 MM BARREL BURRS, 7 CM LENGTH, PURPLE, PACKAGED 6 PER BOX, STERILE SOD BURR 5.5 TAPERED DSPL (6) 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE BURR 4MM ABRADER 180MML DISPOSABLE (3 SOD BURR 4 TAPERED DSPL DYO PWR 4.5 MM TURBOWHISKER STRAIGHT BLADE BLADE 3.5 CURVED CONCAVE FULL RADIUS 5.5 MM ABRADER STRAIGHT BURR DISPOSABLE BL 4.5 ORBIT FR ELITE 5.5 MM ACROMIONIZER STRAIGHT BURR 4.5 MM ORBIT FULL RADIUS CURVED BLADE DYONICS 2.9 MM ABRADER BURRS, 7 CM LENGTH, ORANGE, PACKAGED 6 PER BOX, STERILE 5.5MM INCISOR PLUS PLATINUM SERIES 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE RAZORCUT EP-1 4.5 ORBIT 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE DYONICS 4MM ELITE STONECUTTER BURR MTO BLADE 4.5 SHARP INCISR PLUS DSPL DYO SOD DRILL UNIVERSAL CANNLD 9MM INLINE DRILL BIT 2.9 MM, SUITABLE FOR USE WITH KINSA ANCHOR AND BIORAPTOR 2.9 MM ANCHORS CURVED INCISOR PLUS ELITE BL 4.5MM DRILL 4.5MM SPADE TIP 4.5 MM CUTTER STRAIGHT BLADE 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE HIGH VISIBILITY SHEATH 5.5 MM ABRADER BURR 3.5MM INCISOR PLUS PLAT BLD INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW

Establishment Types

Manufacture Medical Device