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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™ Electrode and Insertion Tube - 10873263007539

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00753
In Commercial Distribution

  • 10873263007539 ()
  • 00873263007532 ()
FC4000

  • Intracerebral cannula, nonimplantable, single-use
  • Depth electrode

microTargeting™ Electrode and Insertion Tube - 10873263001155

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00115
Not in Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable

IV Start Kit - 00616784469225

IV Start Kit, Sterile, 1 Tourniquet (3/4" x 18"), 2 Gauze Sponge (2" x 2", 8-Ply), 1 ID Label, 1 Transparent Dressing, 1 Tape (3/4" x 18"), 1 PVP Pad, 1 Alcohol Pad
Dynarex Corporation
4692
In Commercial Distribution

  • 00616784469225 ()
  • 00616784469232 ()


  • Basic intravenous administration set, noninvasive

ECC 1/4" Pump Pack - 00607567212879

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BEQ-RF32 RotaFlow, BC 60 plus, Cardioplegia Filter, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 7304
Not in Commercial Distribution

  • 00607567212879 ()
709000530

  • Cardiopulmonary bypass system blood tubing set

1/4 ECC Pack Quadrox HMOD 70000 - 00607567211810

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BC 60 plus, SAT/CRIT conn 3/8", Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 8207
Not in Commercial Distribution

  • 00607567211810 ()
701068395R01

  • Cardiopulmonary bypass system blood tubing set

CAREFLOW(TM) 5 LUMEN 9.5FR X 200MM - 00886333617388

Kits Contents : Catheter 9.5FR OD 3.22mmx200mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 10FR OD 3.33mm ID 0.96mm & Floswitch(TM) & Scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681738
In Commercial Distribution

  • 50886333617383 ()
  • 00886333617388 ()

  • Catheter 9.5FR OD 3.22mmx200mm
681738

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 5 LUMEN 9.5FR X 150MM - 00886333617364

Kits Contents : Catheter 9.5FR OD 3.22mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 10FR OD 3.33mm ID 0.96mm, Floswitch(TM) & Scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681736
In Commercial Distribution

  • 50886333617369 ()
  • 00886333617364 ()

  • Catheter 9.5FR OD 3.22mmx150mm
681736

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 4 LUMEN 8.5FR X 200MM - 00886333617340

Kits Contents : Catheter 8.5FR OD 2.90mmx200mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 9FR OD 3.0mm ID 0.96mm, Floswitch(TM) & Scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681734
In Commercial Distribution

  • 50886333617345 ()
  • 00886333617340 ()

  • Catheter 8.5FR OD 2.90mmx200mm
681734

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 4 LUMEN 8.5FR X 150MM - 00886333617326

Kits Contents : Catheter 8.5FR OD 2.90mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 9FR OD 3.0mm ID 0.96mm & Floswitch(TM) & Scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681732
In Commercial Distribution

  • 50886333617321 ()
  • 00886333617326 ()

  • Catheter 8.5FR OD 2.90mmx150mm
681732

  • Vascular catheter introduction set, nonimplantable

CAREFLOW(TM) 1 LUMEN 5FR X 200MM - 00886333616640

Kits Contents : Catheter with Floswitch(TM) 5FR OD 1.75mmx200mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681664
In Commercial Distribution

  • 50886333616645 ()
  • 00886333616640 ()

  • Catheter with Floswitch(TM) 5FR OD 1.75mmx200mm
681664

  • Vascular catheter introduction set, nonimplantable
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