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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No Description
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002137 ()
  • 04053228002130 ()
5970405

  • Interferon gamma release IVD, reagent
SonoTAP II 21G x 150mm wit bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1285-3F150
Not in Commercial Distribution

  • 14048223033286 ()
  • 04048223033289 ()
1285-3F150

  • Peripheral nerve-block sharp needle
SonoTAP II 21G x 110mm with bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1285-3F110
Not in Commercial Distribution

  • 14048223033224 ()
  • 04048223033227 ()
1285-3F110

  • Peripheral nerve-block sharp needle
SonoTAP II 22G x 80mm with bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1285-3E080
Not in Commercial Distribution

  • 14048223033217 ()
  • 04048223033210 ()
1285-3E080

  • Peripheral nerve-block sharp needle
SonoTAP II 22G x 50mm with bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1285-3E050
Not in Commercial Distribution

  • 14048223033200 ()
  • 04048223033203 ()
1285-3E050

  • Peripheral nerve-block sharp needle
Clamping Adapter NRFit -yellow- sterile
Pajunk GmbH Medizintechnologie
001163-37V
Not in Commercial Distribution

  • 14048223029982 ()
  • 04048223029985 ()
001163-37V

  • NRFit/epidural catheter linear connector
BO-SonoInject 25G (0,50) x 50mm cornerstone reflectors, with cable 90cm
Pajunk GmbH Medizintechnologie
001188-81
Not in Commercial Distribution

  • 04048223027189 ()
  • 14048223027186 ()
001188-81

  • Subdermal needle electrode
TuohySono 21G x 120mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4F120
Not in Commercial Distribution

  • 14048223026431 ()
  • 04048223026434 ()
1085-4F120

  • Epidural needle, non-threaded
TuohySono 21G x 70mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4F070
Not in Commercial Distribution

  • 14048223026417 ()
  • 04048223026410 ()
1085-4F070

  • Epidural needle, non-threaded
TuohySono 21G x 50mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4F050
Not in Commercial Distribution

  • 14048223026400 ()
  • 04048223026403 ()
1085-4F050

  • Epidural needle, non-threaded
TuohySono 22G x 120mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4E120
Not in Commercial Distribution

  • 14048223026394 ()
  • 04048223026397 ()
1085-4E120

  • Epidural needle, non-threaded
TuohySono 22G x 90mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4E090
Not in Commercial Distribution

  • 14048223026387 ()
  • 04048223026380 ()
1085-4E090

  • Epidural needle, non-threaded
TuohySono 22G x 70mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4E070
Not in Commercial Distribution

  • 14048223026370 ()
  • 04048223026373 ()
1085-4E070

  • Epidural needle, non-threaded
TuohySono 22G x 50mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4E050
Not in Commercial Distribution

  • 14048223026363 ()
  • 04048223026366 ()
1085-4E050

  • Epidural needle, non-threaded
RFTL Sono 22G x 98,6mm with Cornerstone reflectors,
Pajunk GmbH Medizintechnologie
001175-20B
Not in Commercial Distribution

  • 14048223026080 ()
  • 04048223026083 ()
001175-20B

  • Percutaneous radio-frequency ablation probe cannula, single-use
RFTL Sono 22G x 98,6mm, with Cornerstone reflectors
Pajunk GmbH Medizintechnologie
001175-20A
Not in Commercial Distribution

  • 14048223024642 ()
  • 04048223024645 ()
001175-20A

  • Percutaneous radio-frequency ablation probe cannula, single-use
TuohySono 18G x 150mm with Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1085-4K150
Not in Commercial Distribution

  • 14048223024482 ()
  • 04048223024485 ()
1085-4K150

  • Epidural needle, non-threaded
SonoLong Sono NanoLine SonoLong Nanoline cannula 19G x 75mm facet tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
561187-31A
Not in Commercial Distribution

  • 14048223022099 ()
  • 04048223022092 ()
561187-31A

  • Peripheral anaesthesia catheter set, non-medicated
SonoTAP 21G x 150mm with bevel tip and Cornerstone Reflectors
Pajunk GmbH Medizintechnologie
1185-3F150
Not in Commercial Distribution

  • 14048223021511 ()
  • 04048223021514 ()
1185-3F150

  • Peripheral nerve-block sharp needle
VascularSono 18G x 40mm with Cornerstone Reflectors, sterile
Pajunk GmbH Medizintechnologie
1187-4K040
Not in Commercial Distribution

  • 14048223021504 ()
  • 04048223021507 ()
1187-4K040

  • Vascular catheter introduction set, nonimplantable
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
EV1000 PLATFORM
Edwards Lifesciences LLC
EV1000A
In Commercial Distribution

  • 00690103189650 ()

  • MONITOR: HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS), DATABOX: HEIGHT: 145 MM, WIDTH: 206 MM, DEPTH: 64 MM, WEIGHT: 0.9 KG (2.0 LBS)
EV1000A

  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor
FOGARTY BILIARY BALLOON PROBE 5F 40CM
Edwards Lifesciences LLC
410405F
In Commercial Distribution

  • 00690103043662 ()

  • FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM
410405F

  • Biliary drain
FOGARTY BILIARY BALLOON PROBE 6F 23CM
Edwards Lifesciences LLC
410236F
In Commercial Distribution

  • 00690103043655 ()

  • FRENCH SIZE: 6F (2.0MM), MAXIMUM LIQUID CAPACITY: 1.25ML, MAXIMUM AIR CAPACITY: 2.5ML, MAXIMUM INFLATED BALLOON DIAMETER: 13MM
410236F

  • Biliary drain
FOGARTY BILIARY BALLOON PROBE 5F 23CM
Edwards Lifesciences LLC
410235F
In Commercial Distribution

  • 00690103043648 ()

  • FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM
410235F

  • Biliary drain
FOGARTY IRRIGATION CATHETER 6FR 80CM
Edwards Lifesciences LLC
220806F
In Commercial Distribution

  • 00690103043600 ()

  • USABLE LENGTH: 80CM, FRENCH SIZE: 6F (2.0MM)
220806F

  • Biliary/vascular irrigation catheter
FOGARTY IRRIGATION CATHETER 4F, 80CM
Edwards Lifesciences LLC
220804F
In Commercial Distribution

  • 00690103043594 ()

  • USABLE LENGTH: 80CM, FRENCH SIZE: 4F (1.33MM)
220804F

  • Biliary/vascular irrigation catheter
FOGARTY IRRIGATION CATHETER 10F, 23CM
Edwards Lifesciences LLC
2202310F
In Commercial Distribution

  • 00690103043587 ()

  • USABLE LENGTH: 23CM, FRENCH SIZE: 10F (3.3MM)
2202310F

  • Biliary/vascular irrigation catheter
Porous Vent Plug
Edwards Lifesciences LLC
VP038
In Commercial Distribution

  • 00690103042115 ()
  • 50690103042110 ()

  • 0.952 cm (0.375") x 3.5 cm (1.25")
VP038

  • Catheter orifice occluder
Porous Vent Plug
Edwards Lifesciences LLC
VP025
In Commercial Distribution

  • 00690103042108 ()
  • 50690103042103 ()

  • 0.635 cm (0.25") x 3.3 cm (1.2")
VP025

  • Catheter orifice occluder
Vent Caps
Edwards Lifesciences LLC
SPC2063
In Commercial Distribution

  • 00690103036206 ()
  • 50690103036201 ()
SPC2063

  • Catheter orifice occluder
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