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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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Valved Peelable PTFE Introducer
Greatbatch Ltd
1000092-004
In Commercial Distribution

  • 20821329000700 ()
  • 00821329000706 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.2 mm
  • Sheath ID: 3.1 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 9 French
1000092-004

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000092-003
In Commercial Distribution

  • 20821329000694 ()
  • 00821329000690 ()

  • Dilator OD: 2.9 mm
  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator ID: 0.9 mm
  • Sheath ID: 2.7 mm
  • Sheath Effective Length: 13 cm
  • Catheter Gauge: 8 French
1000092-003

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000092-002
In Commercial Distribution

  • 20821329000687 ()
  • 00821329000683 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator ID: 0.9 mm
  • Dilator OD: 2.6 mm
  • Sheath ID: 2.4 mm
  • Sheath Effective Length: 13 cm
  • Catheter Gauge: 7 French
1000092-002

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000092-001
In Commercial Distribution

  • 20821329000670 ()
  • 00821329000676 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 2.3 mm
  • Sheath ID: 2.1 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 6 French
1000092-001

  • Vascular catheter introduction set, nonimplantable
microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID
FHC, INC.
FC8009-00898
In Commercial Distribution

  • 00873263008980 ()
  • 10873263008987 ()
FC8009

  • Intracerebral cannula, nonimplantable, single-use
microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID
FHC, INC.
FC8009-00119
Not in Commercial Distribution

  • 10873263001193 ()
  • 00873263001196 ()
FC8009

  • Intracerebral cannula, implantable
microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID
FHC, INC.
FC8009-00765
In Commercial Distribution

  • 10873263007652 ()
  • 00873263007655 ()
FC8009

  • Intracerebral cannula, nonimplantable, single-use
60" Uni-Lim Adult Anesthesia Circuit, 10' x .060" ID M/M GSL, B/V Filter 3L not made with latex bag, In-Line Mini HMEF
WESTMED, INC.
9617
In Commercial Distribution

  • 10709078009423 ()
  • 00709078009426 ()


  • Anaesthesia breathing circuit, single-use
Anesthesia Circuit, Adult, 96" Expandable, Parallel Wye, GSE, 10' x .060 ID M/M GSL, B/V Filter, 3L not made with latex bag
WESTMED, INC.
6719
Not in Commercial Distribution

  • 10709078010245 ()
  • 00709078010248 ()


  • Anaesthesia breathing circuit, single-use
BEQ-HMOD 30000-USA Pediatric Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports,Blood Microfilter System SQ 40 S, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 24100
Not in Commercial Distribution

  • 00607567213258 ()
701050175R03

  • Cardiopulmonary bypass system blood tubing set
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