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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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microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive
FHC, INC.
22675Z-00246
In Commercial Distribution

  • 10873263002466 ()
  • 00873263002469 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
22675Z

  • Depth electrode
microTargeting Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive
FHC, INC.
22675L-00244
In Commercial Distribution

  • 10873263002442 ()
  • 00873263002445 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
22675L

  • Depth electrode
microTargeting Array Electrode, sterile, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
22670R-00242
In Commercial Distribution

  • 10873263002428 ()
  • 00873263002421 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22670R

  • Depth electrode
microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive
FHC, INC.
66-ST-14P-00237
Not in Commercial Distribution

  • 10873263002374 ()
  • 00873263002377 ()

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

  • Intracerebral cannula, implantable
microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STar Array Insertion Tubes
FHC, INC.
70-CN-ET-00236
In Commercial Distribution

  • 10873263002367 ()
  • 00873263002360 ()
70-CN-ET

  • Intracerebral cannula, implantable
microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube - 208mm tube length, 1.83mm od, 1.6mm id. PT(DB7): Protective Tube - 209mm tube length, 1.50mm od, .58mm id.
FHC, INC.
70-IT-3007-00234
In Commercial Distribution

  • 10873263002343 ()
  • 00873263002346 ()
70-IT-3007

  • Intracerebral cannula, implantable
microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(AR22): Insertion Tube - 126mm tube length, 1.83mm od, .97mm id. (does not enter brain) IT(AR23): Insertion Tube with stylet - 208mm tube length, .60mm id
FHC, INC.
70-IT-7107-00233
In Commercial Distribution

  • 10873263002336 ()
  • 00873263002339 ()
70-IT-7107

  • Intracerebral cannula, implantable
microTargeting Lead Insertion Tube with Stylet, Sterile, for use with Nexframe and STar Drive
FHC, INC.
70-IT-7147LI-00231
In Commercial Distribution

  • 10873263002312 ()
  • 00873263002315 ()

  • Outer Diameter: 1.83 Millimeter
  • Length: 218.35 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
70-IT-7147LI

  • Intracerebral cannula, implantable
microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use with microTargeting Platform. Contains: IT(AR18): Insertion Tube - 1.83mm od, .97mm id (does not enter brain) IT(AR19): Insertion Tube - 186.7mm tube length, .90mm od, .60mm id
FHC, INC.
70-IT-AR5P-00230
In Commercial Distribution

  • 10873263002305 ()
  • 00873263002308 ()
70-IT-AR5P

  • Intracerebral cannula, implantable
microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use with Stereotactic Frames. Contains: IT(AR16): Insertion Tube - 1.83mm od, .97mm id. (does not enter brain) IT(AR17): Insertion Tube - 241.5mm tube length, .90mm od, .60mm id
FHC, INC.
70-IT-ARP-00227
In Commercial Distribution

  • 10873263002275 ()
  • 00873263002278 ()
70-IT-ARP

  • Intracerebral cannula, implantable
V.A.C. Instill Irrigation Set
KCI USA, INC.
M6275413/5
Not in Commercial Distribution

  • 00878237001639 ()
  • 00878237001417 ()


  • Negative-pressure wound therapy system pump, electric
1000 ml canister (with Gel) for VAC ATS Therapy Systems
KCI USA, INC.
M6275093/5
Not in Commercial Distribution

  • 00878237001455 ()
  • 00878237001431 ()


  • Negative-pressure wound therapy system canister
Vac Granufoam Heel Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275074/5
In Commercial Distribution

  • 00878237001127 ()
  • 00878237001110 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Vac Granufoam Dressing X-Large Featuring Sensatrac Technology
KCI USA, INC.
M8275065/5
In Commercial Distribution

  • 00878237001103 ()
  • 00878237001097 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Vac Granufoam Hand Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275064/5
Not in Commercial Distribution

  • 00878237001080 ()
  • 00878237001073 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
KCI USA, INC.
M8275063/5 M8275063/10
In Commercial Distribution

  • 00878237000892 ()
  • 00878237000878 ()


  • Negative-pressure wound therapy system canister
Vac Granufoam Dressing Round Featuring Sensatrac Technology
KCI USA, INC.
M8275075/5 M8275075/10
Not in Commercial Distribution

  • 00878237000748 ()
  • 00878237000762 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-420810P
In Commercial Distribution

  • 00842071131111 ()
  • 00842071131081 ()

  • Catheter Gauge: 8 French
  • Catheter Gauge: 10 French
E4-420810P, 4-420810P

  • Nasogastric tube holder, noninvasive
5 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-420506P
In Commercial Distribution

  • 00842071131104 ()
  • 00842071131074 ()

  • Catheter Gauge: 6 French
  • Catheter Gauge: 5 French
E4-420506P, 4-420506P

  • Nasogastric tube holder, noninvasive
8F AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-4208P
In Commercial Distribution

  • 00842071131098 ()
  • 00842071131067 ()

  • Catheter Gauge: 8 French
E4-4208P, 4-4208P

  • Nasogastric tube holder, noninvasive
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
Mask, Earloop, Lavender
BENCO DENTAL SUPPLY CO.
3414-744
In Commercial Distribution

  • 20366975000624 ()
  • 10366975000627 ()
  • 00366975000620 ()


  • Surgical/medical face mask, single-use
KWIK-STIK™ Plus A. niger ATCC 6275™
MICROBIOLOGICS INC.
0500UX
Not in Commercial Distribution

  • 40845357012058 ()
  • 10845357012057 ()
0500UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus B. cepacia ATCC 25416™
MICROBIOLOGICS INC.
0488UX
Not in Commercial Distribution

  • 40845357011761 ()
  • 10845357011760 ()
0488UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus C. sporogenes ATCC 11437™
MICROBIOLOGICS INC.
0487UX
Not in Commercial Distribution

  • 40845357011716 ()
  • 10845357011715 ()
0487UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus B. spizizenii ATCC 6633™
MICROBIOLOGICS INC.
0486UX
Not in Commercial Distribution

  • 40845357011648 ()
  • 10845357011647 ()
0486UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus S. aureus ATCC 6538™
MICROBIOLOGICS INC.
0485UX
Not in Commercial Distribution

  • 40845357011549 ()
  • 10845357011548 ()
0485UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus P. aeruginosa ATCC 9027™
MICROBIOLOGICS INC.
0484UX
Not in Commercial Distribution

  • 40845357011440 ()
  • 10845357011449 ()
0484UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus E. coli ATCC 8739™
MICROBIOLOGICS INC.
0483UX
Not in Commercial Distribution

  • 40845357011372 ()
  • 10845357011371 ()
0483UX

  • Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ Plus B. vulgatus ATCC 8482™
MICROBIOLOGICS INC.
0445UX
Not in Commercial Distribution

  • 40845357010412 ()
  • 10845357010411 ()
0445UX

  • Multiple bacteria species culture isolate identification control IVD, kit
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