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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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MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
EITAN MEDICAL LTD
12222-000-0004
In Commercial Distribution

  • 17290109152506 ()
  • 27290109152503 ()


  • Electric infusion pump administration set, single-use
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191405 ()
LM24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191399 ()
LM24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
PowerPort duo M.R.I. Implantable Port with Attachable 9.5F ChronoFlex Open-Ended Dual-Lumen Venous Catheter with Smooth Septum. Intermediate Kit (with Suture Plugs)
Bard Access Systems, Inc.
5829502
In Commercial Distribution

  • 10801741027403 ()
  • 00801741027406 ()

  • Catheter Gauge: 9.5 French
  • Length: 45 Centimeter
5829502

  • Vascular port/catheter
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port with Sharps Safety Features for use with 7.5 - 8 Fr. Catheters
TELEFLEX INCORPORATED
IPN035917
In Commercial Distribution

  • 30801902028137 ()
  • 00801902028136 ()
RH-09901

  • Vascular catheter introduction set, nonimplantable
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
Grasper, 5mm with Spoon with Ratchet Handle: D1368 Composite On/Off, 34cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R/D1368
In Commercial Distribution

  • 00848657026260 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Speedlock Grasper, 5mm with Spoon with Ratchet Handle: 8511-01 Standard Composite, 34cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R/8511-01
In Commercial Distribution

  • 00848657026253 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
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