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 #: 3003604053
·
FEI: 3003604053
·
Expires 2025
Products
1
Proprietary Names
130
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 3003604053
- FEI Number
- 3003604053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 150 Minuteman Rd
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2006-10-05 |
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
Develop Specifications But Do Not Manufacture At This Facility