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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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Coulmed - 10810087350106

Covex Sterile X-Ray Cassette Cover: 24" x 24"
Coulmed Products Group LLC
DI-5503
In Commercial Distribution

  • 30810087350100 ()
  • 10810087350106 ()
DI-5503

  • Medical equipment/instrument drape, single-use

Therapak - 07312058462673

Therapak Acetic Acid 24 Hour Collection (CS/24)
Therapak LLC
ACSK38533
In Commercial Distribution

  • 07312058462673 ()
ACSK38533

  • 24-hour urine specimen container IVD, preservative

BLOXR - 10811042030583

XPF® Patient Protection Shield, 24" x 24"
BLOXR Solutions, LLC
100210
In Commercial Distribution

  • 10811042030583 ()


  • Radiation shielding apron

OBALON® Inflation Can - 00859810006210

OBALON® Inflation Can - component to inflate the OBALON® Balloon System
ReShape Lifesciences Inc.
8200-0001
Not in Commercial Distribution

  • 10859810006217 ()
  • 00859810006210 ()


  • Appetite-suppression gastric balloon inflation gas cartridge

AMICUS Separator - 04086000100137

Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580R
In Commercial Distribution

  • 04086000100137 ()
6R4580R

  • Apheresis system

AMICUS Separator - 04086000100120

Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580
In Commercial Distribution

  • 04086000100120 ()
6R4580

  • Apheresis system

Fem-Flex Femoral Arterial Cannula - 00690103041774

Fem-Flex Femoral Arterial Cannula
Edwards Lifesciences LLC
TFA02425H
In Commercial Distribution

  • 00690103041774 ()
  • 50690103041779 ()

  • 24 Fr. (8.0 mm) X 25 cm (10")
TFA02425H

  • Cardiopulmonary bypass cannula, femoral

Fem-Flex Femoral Arterial Cannula - 00690103041767

Fem-Flex Femoral Arterial Cannula
Edwards Lifesciences LLC
TFA02425
In Commercial Distribution

  • 00690103041767 ()
  • 50690103041762 ()

  • 24 Fr. (8.0 mm) X 25 cm (10")
TFA02425

  • Cardiopulmonary bypass cannula, femoral

Fem-Flex Femoral Arterial Cannula - 00690103041743

Fem-Flex Femoral Arterial Cannula
Edwards Lifesciences LLC
TFA02225
In Commercial Distribution

  • 00690103041743 ()
  • 50690103041748 ()

  • 22 Fr. (7.3 mm) x 25 cm (10")
TFA02225

  • Cardiopulmonary bypass cannula, femoral

Fem-Flex Femoral Arterial Cannula - 00690103041736

Fem-Flex Femoral Arterial Cannula
Edwards Lifesciences LLC
TFA02025
In Commercial Distribution

  • 00690103041736 ()
  • 50690103041731 ()

  • 20 Fr. (6.7 mm) x 25 cm (10")
TFA02025

  • Cardiopulmonary bypass cannula, femoral
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