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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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No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 10mm
In Commercial Distribution

  • D169BISP3510 ()
BISP3510

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 8mm
In Commercial Distribution

  • D169BISP3508 ()
BISP3508

  • Dental implant system
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
7.0mm x 60mm
Not in Commercial Distribution

  • M732M5IVL70600 ()

  • Catheter Working Length: 110 Centimeter
  • Balloon Diameter: 7.0 Millimeter
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Introducer Sheath Compatibility: 7 French
  • Balloon Proximal Outer Diameter (OD): 0.072 Inch
  • Guidewire Diameter: 0.014 Inch
M5IVL7060

  • Ultrasound thrombolysis system catheter, peripheral
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
ACCESS SCIENTIFIC, LLC
3Fr x 5cm
In Commercial Distribution

  • 20859821006692 ()
  • 10859821006695 ()
  • 00859821006698 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 3 French
  • Catheter Length: 5 Centimeter
96001

  • Peripheral vascular catheter
rexpander 3.6 x 9
Rex Implants, Inc.
3.6 x 9
In Commercial Distribution

  • D894BE210 ()

  • Height: 9 Millimeter
  • Width: 3.6 Millimeter
BE-21

  • Maxillofacial bone separator
No Description
CRAWFORD HEALTHCARE LIMITED
16 x 16in
In Commercial Distribution

  • 05060077233706 ()
  • 05060077233690 ()
  • 05060077233683 ()

  • Length: 16 Inch
  • Height: 16 Inch
CWL1163

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
PowerHeal 3-layer clear adhesive, 6" x 6" "
Vomaris Wound Care, Inc.
6" x 6"
In Commercial Distribution

  • 00810198031546 ()

  • Length: 6 Inch
  • Width: 6 Inch
PFK-6060

  • Bioelectric wound dressing
Interbody Fusion Device 7DEG x 26L x 10W x 15H
CAMBER SPINE TECHNOLOGIES, LLC
IInterbody Fusion Device 7DEG x 26L x 10W x 15H
In Commercial Distribution

  • B030CX2610150 ()
CX-261015

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 14H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 14H
In Commercial Distribution

  • B030CX2610140 ()
CX-261014

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 13H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 13H
In Commercial Distribution

  • B030CX2610130 ()
CX-261013

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 12H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 12H
In Commercial Distribution

  • B030CX2610120 ()
CX-261012

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 11H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 11H
In Commercial Distribution

  • B030CX2610110 ()
CX-261011

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 10H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 10H
In Commercial Distribution

  • B030CX2610100 ()
CX-261010

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 8H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 8H
In Commercial Distribution

  • B030CX2610080 ()
CX-261008

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 26L x 10W x 7H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 26L x 10W x 7H
In Commercial Distribution

  • B030CX2610070 ()
CX-261007

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 15H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 15H
In Commercial Distribution

  • B030CX2210150 ()
CX-221015

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 14H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 14H
In Commercial Distribution

  • B030CX2210140 ()
CX-221014

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 13H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 13H
In Commercial Distribution

  • B030CX2210130 ()
CX-221013

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 12H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 12H
In Commercial Distribution

  • B030CX2210120 ()
CX-221012

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 11H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 11H
In Commercial Distribution

  • B030CX2210110 ()
CX-221011

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 10H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 10H
In Commercial Distribution

  • B030CX2210100 ()
CX-221010

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 9H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 9H
In Commercial Distribution

  • B030CX2210090 ()
CX-221009

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 8H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 8H
In Commercial Distribution

  • B030CX2210080 ()
CX-221008

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 7H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 7H
In Commercial Distribution

  • B030CX2210070 ()
CX-221007

  • Polymeric spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 8mm x 15mm x 0 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P281508S1 ()
502-P281508-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 26mm x 12mm x 15mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P2615812S1 ()
502-P2615812S-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 24mm x 10mm x 7mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P247810S1 ()
502P247810S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 22mm x 10mm x 9mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P229810S1 ()
502-P229810-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 30mm x 12mm x 15mm x 2 °, PEEK, Sterile
In Commercial Distribution

  • M695302P301521S1 ()
302-P301521S-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 10mm x 11mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M695302P2811010S1 ()
302P2811010S

  • Metal-polymer composite spinal interbody fusion cage
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