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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Quantum 2 - 00817470001891

FA QUANTUM 2 CONTROLLER
Smith & Nephew, Inc.
H4500-00
In Commercial Distribution

  • 00817470001891 ()
H4500-00

  • Electrosurgical system generator

Coblation - 00817470001860

4.5 MM INTEGRATED CABLE WAND ICW, ELIMINATOR 90 DEGREE
Smith & Nephew, Inc.
AC1345-01
In Commercial Distribution

  • 00817470001860 ()
AC1345-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Coblation - 00817470001853

2.5MM RAZOR 45 DEGREE ICW
Smith & Nephew, Inc.
AC5520-01
In Commercial Distribution

  • 00817470001853 ()
AC5520-01

  • Universal foot-controlled electrosurgical diathermy system conducting unit, single-use

Coblation - 00817470001839

3.5 MM INTEGRATED CABLE WAND ICW, RIGHT ANGLE 90 DEGREE
Smith & Nephew, Inc.
AC1340-01
In Commercial Distribution

  • 00817470001839 ()
AC1340-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

COBLATOR II Controller 120V (SRVC controller-only) - 00817470001792

COBLATOR II Controller Only 120V Refurb
Smith & Nephew, Inc.
13546-59
In Commercial Distribution

  • 00817470001792 ()
13546-59

  • Electrosurgical system generator

Coblation - 00817470001761

AMBIENT MEGAVAC 90
Smith & Nephew, Inc.
ASCA5001-01
In Commercial Distribution

  • 00817470001761 ()
ASCA5001-01

  • Universal hand-controlled electrosurgical diathermy system conducting unit, single-use

N/A - 00817470001723

RF12000 SRVC CONTROLLER-ONLY PACKAGE
Smith & Nephew, Inc.
19062-59
In Commercial Distribution

  • 00817470001723 ()
19062-59

  • Electrosurgical system generator

Coblation - 00817470001716

3.5 MM STARVAC 90 INTEGRATED CABLE WAND ICW, 90 DEGREE
Smith & Nephew, Inc.
ASC4251-01
In Commercial Distribution

  • 00817470001716 ()
ASC4251-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Coblation - 00817470001693

3.0 MM NON-INTEGRATED CABLE WAND NON-ICW, STRAIGHT SABER
Smith & Nephew, Inc.
A4300-01
In Commercial Distribution

  • 00817470001693 ()
A4300-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

SMARTSTITCH - 00817470001679

SMARTSTITCH SUTURE DEVICE HANDLE
Smith & Nephew, Inc.
OM-8000
In Commercial Distribution

  • 00817470001679 ()
OM-8000

  • Suturing unit, reusable
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