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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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Lucitone® HIPA - D0019059540

Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059350

Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059340

Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059330

Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059320

Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin

Britedent - D974BSI20031

Micro Applicators Regular (2.00mm) Purple
Bright Supply, Inc.
BSI-1501
In Commercial Distribution

  • D974BSI20032 ()
  • D974BSI20031 ()
  • D974BSI20033 ()
  • D974BSI20030 ()


  • Dental material application tool, single-use

CosmoLock Pedicle Screw System - B07311LCL00000

Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw

XO Cross 14 - B090C140900

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090
Not in Commercial Distribution

  • B090C140901 ()
  • B090C140900 ()
  • B090C140902 ()

  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C351350

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
Not in Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C141750

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175
Not in Commercial Distribution

  • B090C141751 ()
  • B090C141750 ()
  • B090C141752 ()

  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
C14-175

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C141350

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135
Not in Commercial Distribution

  • B090C141351 ()
  • B090C141350 ()
  • B090C141352 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135

  • Vascular guide-catheter, single-use

Ventlab - 10889483102138

PEDI,MANOMETER,PEEP ATTACHED,14',SOFT
VENTLAB, LLC
AF2100MB-PWTS4
In Commercial Distribution

  • 20889483102135 ()
  • 10889483102138 ()

  • Total Volume: 1000 Milliliter


  • Pulmonary resuscitator, manual, single-use

Ventlab - 10889483085790

INFANT AIRFLOW W/MANOMETER AND 2 MASKS
VENTLAB, LLC
AF3100MB-M01
In Commercial Distribution

  • 20889483085797 ()
  • 10889483085790 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use

Sunmed - 10889483040478

E/T TUBE NO-CUFF 5.0mm 20FR
SUNMED, LLC
1-7330-50
In Commercial Distribution

  • 20889483040475 ()
  • 10889483040478 ()

  • Length: 245 Millimeter
  • Outer Diameter: 6.67 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Basic endotracheal tube, single-use

Uniseal Unimask - 20744514711246

Ear Loop Surgical Face Mask, Pink, Non-Sterile
Uniseal
711-2P
In Commercial Distribution

  • 30744514711243 ()
  • 20744514711246 ()
  • 10744514711249 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

NAMIC - H9656062093230

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209323
In Commercial Distribution

  • H9656062093231 ()
  • H9656062093230 ()


  • Angiography kit

NAMIC - H9656062093170

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209317
In Commercial Distribution

  • H9656062093171 ()
  • H9656062093170 ()


  • Angiography kit

NAMIC - H9656062093160

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209316
In Commercial Distribution

  • H9656062093161 ()
  • H9656062093160 ()


  • Angiography kit

NAMIC - H9656062093150

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209315
In Commercial Distribution

  • H9656062093151 ()
  • H9656062093150 ()


  • Angiography kit

NAMIC - H9656062093130

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209313
In Commercial Distribution

  • H9656062093131 ()
  • H9656062093130 ()


  • Angiography kit

NAMIC - H965606209130

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
60620913
In Commercial Distribution

  • H965606209130 ()
  • H965606209131 ()


  • Angiography kit

NAMIC - H9656062091270

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209127
In Commercial Distribution

  • H9656062091271 ()
  • H9656062091270 ()


  • Angiography kit

NAMIC - H9656062091230

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209123
In Commercial Distribution

  • H9656062091231 ()
  • H9656062091230 ()


  • Angiography kit

NAMIC - H9656062091220

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209122
In Commercial Distribution

  • H9656062091221 ()
  • H9656062091220 ()


  • Angiography kit

NAMIC - H9656062091200

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606209120
In Commercial Distribution

  • H9656062091201 ()
  • H9656062091200 ()


  • Angiography kit

NAMIC - H9656062088130

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606208813
In Commercial Distribution

  • H9656062088131 ()
  • H9656062088130 ()


  • Angiography kit

NAMIC - H9656062088100

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606208810
In Commercial Distribution

  • H9656062088101 ()
  • H9656062088100 ()


  • Angiography kit

NAMIC - H965606204650

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
60620465
In Commercial Distribution

  • H965606204651 ()
  • H965606204650 ()


  • Angiography kit

NAMIC - H9656061604120

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606160412
In Commercial Distribution

  • H9656061604121 ()
  • H9656061604120 ()


  • Angiography kit

NAMIC - H9656061190710

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
606119071
In Commercial Distribution

  • H9656061190711 ()
  • H9656061190710 ()


  • Angiography kit

NAMIC - H96560611041320

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061104132
In Commercial Distribution

  • H96560611041321 ()
  • H96560611041320 ()


  • Angiography kit

NAMIC - H96560611021410

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061102141
In Commercial Distribution

  • H96560611021411 ()
  • H96560611021410 ()


  • Angiography kit

NAMIC - H96560610986220

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061098622
In Commercial Distribution

  • H96560610986221 ()
  • H96560610986220 ()


  • Angiography kit

NAMIC - H96560610980810

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061098081
In Commercial Distribution

  • H96560610980811 ()
  • H96560610980810 ()


  • Angiography kit

NAMIC - H96560610929510

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061092951
In Commercial Distribution

  • H96560610929510 ()
  • H96560610929511 ()


  • Angiography kit

NAMIC - H96560610915310

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061091531
In Commercial Distribution

  • H96560610915311 ()
  • H96560610915310 ()


  • Angiography kit

NAMIC - H96560610896910

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061089691
In Commercial Distribution

  • H96560610896911 ()
  • H96560610896910 ()


  • Angiography kit

NAMIC - H96560610880110

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061088011
In Commercial Distribution

  • H96560610880111 ()
  • H96560610880110 ()


  • Angiography kit

NAMIC - H96560610691410

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061069141
In Commercial Distribution

  • H96560610691411 ()
  • H96560610691410 ()


  • Angiography kit

NAMIC - H96560610584320

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061058432
In Commercial Distribution

  • H96560610584321 ()
  • H96560610584320 ()


  • Angiography kit

NAMIC - H96560610560110

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061056011
In Commercial Distribution

  • H96560610560111 ()
  • H96560610560110 ()


  • Angiography kit

NAMIC - H96560610551420

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061055142
In Commercial Distribution

  • H96560610551421 ()
  • H96560610551420 ()


  • Angiography kit

NAMIC - H96560610551410

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061055141
In Commercial Distribution

  • H96560610551411 ()
  • H96560610551410 ()


  • Angiography kit

NAMIC - H96560610548410

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061054841
In Commercial Distribution

  • H96560610548411 ()
  • H96560610548410 ()


  • Angiography kit

NAMIC - H96560610461310

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061046131
In Commercial Distribution

  • H96560610461311 ()
  • H96560610461310 ()


  • Angiography kit

NAMIC - H96560610457310

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061045731
In Commercial Distribution

  • H96560610457311 ()
  • H96560610457310 ()


  • Angiography kit

NAMIC - H96560610452630

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061045263
In Commercial Distribution

  • H96560610452631 ()
  • H96560610452630 ()


  • Angiography kit

NAMIC - H96560610452620

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061045262
In Commercial Distribution

  • H96560610452621 ()
  • H96560610452620 ()


  • Angiography kit

NAMIC - H96560610452610

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061045261
In Commercial Distribution

  • H96560610452611 ()
  • H96560610452610 ()


  • Angiography kit

NAMIC - H96560610447510

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
6061044751
In Commercial Distribution

  • H96560610447511 ()
  • H96560610447510 ()


  • Angiography kit
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