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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Vac Veratrac Duo Tube Set
KCI USA, INC.
ULTDUO0500
In Commercial Distribution

  • 00849554001374 ()
  • 00849554000162 ()


  • Negative-pressure wound therapy tubing set
KCI NPWT Gauze Dressing Large Featuring Sensatrac Technology
KCI USA, INC.
413716
In Commercial Distribution

  • 00849554001336 ()
  • 00849554001251 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Vac Veraflo Cleanse Dressing System
KCI USA, INC.
ULTCL05MD
In Commercial Distribution

  • 00849554001329 ()
  • 00849554000179 ()


  • Irrigation negative-pressure wound therapy dressing
VAC Veraflo Dressing System Medium
KCI USA, INC.
ULTVFL05MD
In Commercial Distribution

  • 00849554001305 ()
  • 00849554000155 ()


  • Irrigation negative-pressure wound therapy dressing
Vac Veraflo Dressing System Small
KCI USA, INC.
ULTVFL05SM
In Commercial Distribution

  • 00849554001299 ()
  • 00849554000148 ()


  • Irrigation negative-pressure wound therapy dressing
Abthera Tubing Set
KCI USA, INC.
370642
In Commercial Distribution

  • 00849554001275 ()
  • 00849554000230 ()


  • Negative-pressure wound therapy tubing set
Abthera Open Abdomen Dressing
KCI USA, INC.
370605
In Commercial Distribution

  • 00849554001268 ()
  • 00849554000223 ()


  • Negative-pressure wound therapy open-abdomen dressing
Cellutome Epidermal Harvesting System Harvester (5.0cm)
KCI USA, INC.
CT-H50
In Commercial Distribution

  • 00849554001220 ()
  • 00849554001206 ()


  • Dermatome handpiece, electrically-powered
Prevena Plus 150 ml Canister
KCI USA, INC.
Prevena Plus 150 ml Canister
In Commercial Distribution

  • 00849554005310 ()
  • 00849554005327 ()


  • Negative-pressure wound therapy system, electric, single-use
Vac Veraflo Cleanse Choice Dressing- Medium
KCI USA, INC.
ULTVCC05MD
In Commercial Distribution

  • 00849554004733 ()
  • 00849554004726 ()


  • Irrigation negative-pressure wound therapy dressing
Cellutome Epidermal Harvesting System Harvester (2.5cm)
KCI USA, INC.
CT-H25
In Commercial Distribution

  • 00849554001213 ()
  • 00849554001190 ()


  • Dermatome handpiece, electrically-powered
Prevena Customizable Dressing
KCI USA, INC.
Prevena Customizable Dressing
In Commercial Distribution

  • 00849554000087 ()
  • 00849554000070 ()


  • Negative-pressure wound therapy system, electric, single-use
Prevena 45 ml canister
KCI USA, INC.
Prevena 45 ml canister
In Commercial Distribution

  • 00849554000032 ()
  • 00849554000025 ()


  • Negative-pressure wound therapy system, electric, single-use
Prevena Peel & Place Dressing- 20 cm Prevena Patch Strips
KCI USA, INC.
Prevena Peel & Place Dressing- 20 cm
In Commercial Distribution

  • 00849554000018 ()
  • 00849554000131 ()


  • Negative-pressure wound therapy system, electric, single-use
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 18964050362022 ()
  • 08964050362025 ()

  • Length: 130 Millimeter
  • Width: 100 Millimeter
  • Thickness: 0.02 Millimeter
36202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWLP(BP)(BP16)-00942
In Commercial Distribution

  • 10873263009427 ()
  • 00873263009420 ()
MTDWLP(BP)(BP16)

  • Depth electrode
microTargeting™ Insertion Tube with Stylet, 74mm
FHC, INC.
66-IT-CV2P-00926
In Commercial Distribution

  • 10873263009267 ()
  • 00873263009260 ()
66-IT-CV2P

  • Intracerebral cannula, nonimplantable, reusable
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(BP)(BP11)-00924
In Commercial Distribution

  • 10873263009243 ()
  • 00873263009246 ()
MTDWZP(BP)(BP11)

  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AR)(MP7)-00923
In Commercial Distribution

  • 10873263009236 ()
  • 00873263009239 ()
MTDWZP(AR)(MP7)

  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AO)(A11)-00921
In Commercial Distribution

  • 10873263009212 ()
  • 00873263009215 ()
MTDWZP(AO)(A11)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
FHC, INC.
MTDWLP(SP)(MP4)-00915
In Commercial Distribution

  • 10873263009151 ()
  • 00873263009154 ()
MTDWLP(SP)(MP4)

  • Depth electrode
microTargeting Insertion Tube with Stylet, Sterile
FHC, INC.
66-IT-AO11P-00867
In Commercial Distribution

  • 10873263008673 ()
  • 00873263008676 ()
66-IT-AO11P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(AR7)-00865
In Commercial Distribution

  • 00873263008652 ()
  • 10873263008659 ()
MTDWZP(AR)(AR7)

  • Depth electrode
microTargeting Insertion Tube with Stylet, 258.9mm
FHC, INC.
66-IT-ME1P-00858
In Commercial Distribution

  • 10873263008581 ()
  • 00873263008584 ()
66-IT-ME1P

  • Intracerebral cannula, nonimplantable, reusable
33 cm Lead Insertion Tube Set, for use with microTargeting STar Drive
FHC, INC.
70-IT-1023-00849
In Commercial Distribution

  • 10873263008499 ()
  • 00873263008492 ()
70-IT-1023

  • Intracerebral cannula, nonimplantable, single-use
microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tube - 205.6mm tube length, 1.83mm od, 1.6mm id PT(KH1): Protective Tube - 0.58mm id. Nexframe Stylet.
FHC, INC.
66-IT-4010S-00848
In Commercial Distribution

  • 10873263008482 ()
  • 00873263008485 ()
66-IT-4010S

  • Intracerebral cannula, nonimplantable, single-use
2.0mm O.D Insertion Tube with Stylet 127.1 mm
FHC, INC.
66-IT-SG1P-00842
In Commercial Distribution

  • 10873263008420 ()
  • 00873263008423 ()
66-IT-SG1P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting DP Stylet, for use with mT Drive and STar Drive
FHC, INC.
66-ST-12P-00824
In Commercial Distribution

  • 10873263008246 ()
  • 00873263008249 ()

  • Length: 244.5 Millimeter
66-ST-12P

  • Scalpel, single-use
microTargeting DP Stylet, 1x, for use with mT Drive and STar Drive
FHC, INC.
66-ST-14P-00822
In Commercial Distribution

  • 10873263008222 ()
  • 00873263008225 ()

  • Outer Diameter: 1.83 Millimeter
  • Length: 204 Millimeter
66-ST-14P

  • Scalpel, single-use
microTargeting™ Insertion Tube with Stylet, sterile
FHC, INC.
66-IT-15P-00821
In Commercial Distribution

  • 10873263008215 ()
  • 00873263008218 ()
66-IT-15P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting™ Single Electrode Insertion Tube Set with Bullet Tip Stylet at target, 1x, Sterile. Contains: IT(BP11) Insertion Tube – 219mm tube length, 1.83mm od, 1.6mm id PT(JN11) Protective Tube - 1.27mm od, .84mm id
FHC, INC.
66-IT-11P-00801
In Commercial Distribution

  • 10873263008017 ()
  • 00873263008010 ()
66-IT-11P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting™ Platform Platinum 5X Sterile
FHC, INC.
45375Z-00800
In Commercial Distribution

  • 10873263008000 ()
  • 00873263008003 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Length: 212.72 Millimeter
  • Length: 3 Millimeter
45375Z

  • Depth electrode
microTargeting™ Platform Electrodes 5x Sterile
FHC, INC.
44375Z-00798
In Commercial Distribution

  • 10873263007980 ()
  • 00873263007983 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
44375Z

  • Depth electrode
microTargeting™ Single Frame Platinum 5X Sterile
FHC, INC.
35385Z-00796
In Commercial Distribution

  • 10873263007966 ()
  • 00873263007969 ()

  • Length: 3 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
35385Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 5X Sterile
FHC, INC.
34385Z-00794
In Commercial Distribution

  • 10873263007942 ()
  • 00873263007945 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
34385Z

  • Depth electrode
microTargeting™ Array Frame Platinum 5X Sterile
FHC, INC.
25375Z-00792
In Commercial Distribution

  • 10873263007928 ()
  • 00873263007921 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
25375Z

  • Depth electrode
microTargeting™ Array Electrodes 5x Sterile
FHC, INC.
22375Z-00790
In Commercial Distribution

  • 10873263007904 ()
  • 00873263007907 ()

  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
22375Z

  • Depth electrode
microTargeting Insertion Tube with Stylet, Sterile
FHC, INC.
66-IT-AO6P-00736
In Commercial Distribution

  • 10873263007362 ()
  • 00873263007365 ()

  • Outer Diameter: 1.8 Millimeter
  • Length: 162 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
66-IT-AO6P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation, Presterile
FHC, INC.
MTBPBP(DT1)-00672
In Commercial Distribution

  • 10873263006723 ()
  • 00873263006726 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.63 Millimeter
  • Impedance: Megaohms
MTBPBP(DT1)

  • Depth electrode
microTargeting™ Electrode, back loaded, presterile, tungsten
FHC, INC.
MTBWLP(ZK1)-00669
In Commercial Distribution

  • 10873263006693 ()
  • 00873263006696 ()

  • Outer Diameter: 0.34 Millimeter
  • Length: 2 Millimeter
  • Length: 250 Millimeter
MTBWLP(ZK1)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, DZAP
FHC, INC.
MTDWZP(SS)(BP8)-00661
In Commercial Distribution

  • 10873263006617 ()
  • 00873263006610 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.7 Millimeter
  • Length: 268.4 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
MTDWZP(SS)(BP8)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
FHC, INC.
MTDWLP(SS)(BP8)-00659
In Commercial Distribution

  • 10873263006594 ()
  • 00873263006597 ()

  • Outer Diameter: 0.7 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 268.4 Millimeter
  • Impedance: Megaohms
MTDWLP(SS)(BP8)

  • Depth electrode
microTargeting™ Electrode, differential, sterile, platinum/iridium
FHC, INC.
MTDPZP(AO)(AO1)-00651
In Commercial Distribution

  • 10873263006518 ()
  • 00873263006511 ()

  • Length: 3 Millimeter
  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 282 Millimeter
  • Length: 274 Millimeter
MTDPZP(AO)(AO1)

  • Depth electrode
microTargeting™ Lead Insertion Tube with Stylet, Sterile, for use with stereotactic frame, 5x
FHC, INC.
66-IT-AR14P-00649
In Commercial Distribution

  • 10873263006495 ()
  • 00873263006498 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 267.85 Millimeter
66-IT-AR14P

  • Intracerebral cannula, nonimplantable, single-use
microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Platform
FHC, INC.
MTDPZP(PA)(MP1)-00642
In Commercial Distribution

  • 10873263006426 ()
  • 00873263006429 ()

  • Length: 215.72 Millimeter
  • Outer Diameter: 0.5 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
  • Impedance: Megaohms
MTDPZP(PA)(MP1)

  • Depth electrode
microTargeting(TM) Electrode, sterile, 5x, D.ZAP(L), for use with Platform
FHC, INC.
MTDPLP(PA)(MP1)-00640
In Commercial Distribution

  • 10873263006402 ()
  • 00873263006405 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.5 Millimeter
  • Length: 220.72 Millimeter
  • Length: 215.72 Millimeter
  • Length: 10 Millimeter
MTDPLP(PA)(MP1)

  • Depth electrode
microTargeting Sterotactic Frame Insertion Tube Set, 5X Contains: IT(BP13): Insertion Tube - 194mm tube length, 1.83mm od, 1.6mm id PT(BP13): Protective Tube - 1.0mm id SA8-87-02: Stylet - 266.4mm length
FHC, INC.
66-IT-14S-00620
In Commercial Distribution

  • 10873263006204 ()
  • 00873263006207 ()
66-IT-14S

  • Intracerebral cannula, implantable
microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 10mm above target, for use with Nexframe and Nexdrive
FHC, INC.
66-IT-AR43P-00615
In Commercial Distribution

  • 10873263006150 ()
  • 00873263006153 ()

  • Outer Diameter: 0.9 Millimeter
  • Lumen/Inner Diameter: 0.6 Millimeter
  • Length: 201.6 Millimeter
66-IT-AR43P

  • Intracerebral cannula, implantable
microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 10mm above target, for use with Nexframe and Nexdrive
FHC, INC.
66-IT-AR42P-00614
In Commercial Distribution

  • 10873263006143 ()
  • 00873263006146 ()

  • Length: 201.6 Millimeter
  • Outer Diameter: 0.9 Millimeter
  • Lumen/Inner Diameter: 0.6 Millimeter
66-IT-AR42P

  • Intracerebral cannula, implantable
Array Electrode Insertion Tube with Stylet, Sterile
FHC, INC.
66-IT-7100-00609
In Commercial Distribution

  • 10873263006099 ()
  • 00873263006092 ()

  • Length: 217 Millimeter
  • Outer Diameter: 0.89 Millimeter
  • Lumen/Inner Diameter: 0.58 Millimeter
66-IT-7100

  • Intracerebral cannula, implantable
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