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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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VascularSono 21G x 35mm with Cornerstone Reflectors, sterile
Pajunk GmbH Medizintechnologie
1187-4F035
Not in Commercial Distribution

  • 14048223021344 ()
  • 04048223021347 ()
1187-4F035

  • Vascular catheter introduction set, nonimplantable
SonoTAP 22G x 50mm with bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1185-3E050
Not in Commercial Distribution

  • 14048223021214 ()
  • 04048223021217 ()
1185-3E050

  • Peripheral nerve-block sharp needle
TuohySono 18G x 120mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4K120
Not in Commercial Distribution

  • 14048223021191 ()
  • 04048223021194 ()
1085-4K120

  • Epidural needle, non-threaded
VascularSono 18G x 100mm with Cornerstone Reflectors, sterile
Pajunk GmbH Medizintechnologie
1187-4K100
Not in Commercial Distribution

  • 14048223021160 ()
  • 04048223021163 ()
1187-4K100

  • Vascular catheter introduction set, nonimplantable
VascularSono 18G x 70mm with Cornerstone Reflectors, sterile
Pajunk GmbH Medizintechnologie
1187-4K070
Not in Commercial Distribution

  • 14048223021153 ()
  • 04048223021156 ()
1187-4K070

  • Vascular catheter introduction set, nonimplantable
TuohySono 18G x 90mm with Cornerstone reflectors
Pajunk GmbH Medizintechnologie
1085-4K090
Not in Commercial Distribution

  • 14048223020323 ()
  • 04048223020326 ()
1085-4K090

  • Epidural needle, non-threaded
No Description
BIOMET SPINE LLC
60235W
In Commercial Distribution

  • 00880304962637 ()

  • ESL - 15MM WIDE
60235W

  • Vertebral body prosthesis
No Description
BIOMET SPINE LLC
60234W
In Commercial Distribution

  • 00880304962620 ()

  • ESL - 14MM WIDE
60234W

  • Vertebral body prosthesis
No Description
BIOMET SPINE LLC
60233
In Commercial Distribution

  • 00880304962613 ()

  • ESL - 13MM
60233

  • Polymeric spinal interbody fusion cage
No Description
BIOMET SPINE LLC
60232
In Commercial Distribution

  • 00880304962606 ()

  • ESL - 12MM
60232

  • Polymeric spinal interbody fusion cage
No Description
BIOMET SPINE LLC
60231
In Commercial Distribution

  • 00880304962590 ()

  • ESL - 11MM
60231

  • Polymeric spinal interbody fusion cage
No Description
BIOMET SPINE LLC
60230
In Commercial Distribution

  • 00880304962583 ()

  • ESL - 10MM
60230

  • Polymeric spinal interbody fusion cage
No Description
BIOMET SPINE LLC
60229
In Commercial Distribution

  • 00880304962576 ()

  • ESL - 9MM
60229

  • Polymeric spinal interbody fusion cage
No Description
BIOMET SPINE LLC
60228
In Commercial Distribution

  • 00880304962569 ()

  • ESL - 8MM
60228

  • Polymeric spinal interbody fusion cage
PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
PC2K
In Commercial Distribution

  • 00690103193473 ()

  • Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m
PC2K

  • Patient monitoring system module, blood pressure, noninvasive
  • Patient positioning sensor
  • General-purpose multi-parameter bedside monitor
CLEARSIGHT FINGER CUFF LARGE MULTI PACK
Edwards Lifesciences LLC
CSCL
In Commercial Distribution

  • 00690103193367 ()
  • 20690103193361 ()
  • 50690103193362 ()

  • LARGE
CSCL

  • Blood pressure cuff, single-use
  • Patient positioning sensor
CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK
Edwards Lifesciences LLC
CSCM
In Commercial Distribution

  • 00690103193350 ()
  • 20690103193354 ()

  • MEDIUM
CSCM

  • Blood pressure cuff, single-use
CLEARSIGHT FINGER CUFF SMALL MULTI PACK
Edwards Lifesciences LLC
CSCS
In Commercial Distribution

  • 00690103193343 ()
  • 20690103193347 ()

  • SMALL
CSCS

  • Blood pressure cuff, single-use
EV1000 DATABOX ASSEMBLY
Edwards Lifesciences LLC
EV1000DB
In Commercial Distribution

  • 00690103190113 ()

  • Height: 145 mm, Width: 206 mm, Depth: 64 mm, Weight: 0.9 kg (2.0 lbs)
EV1000DB

  • General-purpose multi-parameter bedside monitor
EV1000 MONITOR
Edwards Lifesciences LLC
EV1000M
In Commercial Distribution

  • 00690103190106 ()

  • HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS)
EV1000M

  • Patient monitoring system module, blood pressure, noninvasive
  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor
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