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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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Ossi Classic IH - D169BSIH0510

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

  • D169BSIH0510 ()
BIOSP0510IH

  • Dental implant system

Ossi Classic IH - D169BSIH0508

No Description
QUICKDENT DEVICES PRIVATE LIMITED
5.0 x 8mm
In Commercial Distribution

  • D169BSIH0508 ()
BIOSP0508IH

  • Dental implant system

Korticale SP - D169BISP4216

No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 16mm
In Commercial Distribution

  • D169BISP4216 ()
BISP4216

  • Dental implant system

Korticale SP - D169BISP4214

No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 14mm
In Commercial Distribution

  • D169BISP4214 ()
BISP4214

  • Dental implant system

Korticale SP - D169BISP4212

No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 12mm
In Commercial Distribution

  • D169BISP4212 ()
BISP4212

  • Dental implant system

Korticale SP - D169BISP4210

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

  • D169BISP4210 ()
BISP4210

  • Dental implant system

Korticale SP - D169BISP4208

No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 8mm
In Commercial Distribution

  • D169BISP4208 ()
BISP4208

  • Dental implant system

Korticale SP - D169BISP3516

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 16mm
In Commercial Distribution

  • D169BISP3516 ()
BISP3516

  • Dental implant system

Korticale SP - D169BISP3514

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 14mm
In Commercial Distribution

  • D169BISP3514 ()
BISP3514

  • Dental implant system

Korticale SP - D169BISP3512

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 12mm
In Commercial Distribution

  • D169BISP3512 ()
BISP3512

  • Dental implant system

Korticale SP - D169BISP3510

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

  • D169BISP3510 ()
BISP3510

  • Dental implant system

Korticale SP - D169BISP3508

No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 8mm
In Commercial Distribution

  • D169BISP3508 ()
BISP3508

  • Dental implant system

Shockwave M5 - M732M5IVL70600

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

ARTERIAL WAND - 00859821006698

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 - D894BE210

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

KerraCel Ag - 05060077233683

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 - 00810198031546

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

TLS 5.0 - B030CX2610150

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

TLS 5.0 - B030CX2610140

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

TLS 5.0 - B030CX2610130

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
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