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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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GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS 2.0
In Commercial Distribution

  • 00840682141161 ()


  • Breast ultrasound imaging system
GONIOMETER
FX SOLUTIONS
902-0002
In Commercial Distribution

  • 03701037305577 ()
902-0002

  • Manual goniometer
  • Orthopaedic surgical procedure kit, non-medicated, reusable
Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable
24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable
IMS STERILIZATION WRAP 24 x 24 100 SHEET
HU-FRIEDY MFG. CO., LLC
IMS-1210H
In Commercial Distribution

  • 10889950002732 ()
  • 10889950075033 ()
IMS-1210H

  • Sterilization packaging, single-use
X-ray Cassette Cover 24 x 24 Adhesive Closure
MEDICAL TECHNIQUE, INC.
9954-50
In Commercial Distribution

  • 00815384022360 ()
  • 00815384022353 ()
  • 00815384022346 ()
9954-50

  • Instrument/equipment drape, single-use, sterile
24" DRYER, MED. GRAPHICS 24" DRYER, MED. GRAPHICS
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106901821 ()
  • 00840106901784 ()
  • 00840106901814 ()
  • 00840106901807 ()
  • 00840106901791 ()
ME-050-03-99

  • Gas-sampling/monitoring respiratory tubing, single-use
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 Acetic Acid 24 Hour Collection (CS/24)
Therapak LLC
ACSK38533
In Commercial Distribution

  • 07312058462673 ()
ACSK38533

  • 24-hour urine specimen container IVD, preservative
XPF® Patient Protection Shield, 24" x 24"
BLOXR Solutions, LLC
100210
In Commercial Distribution

  • 10811042030583 ()


  • Radiation shielding apron
BluEX-A (24 X 32 X 24 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2425S
In Commercial Distribution

  • 08809986465870 ()


  • Metallic spinal interbody fusion cage
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
OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System
ReShape Lifesciences Inc.
8200-0001
Not in Commercial Distribution

  • 10859810006019 ()
  • 00859810006012 ()


  • Appetite-suppression gastric balloon
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
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
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
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
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
Edwards Lifesciences LLC
TFA02025
In Commercial Distribution

  • 00690103041736 ()
  • 50690103041731 ()

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

  • Cardiopulmonary bypass cannula, femoral
FEMORAL VENOUS CANNULA
Edwards Lifesciences LLC
LV89530
Not in Commercial Distribution

  • 00690103032451 ()
  • 50690103032456 ()

  • 30 FR. (10.0 MM) X 60 CM (24")
LV89530

  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
LV89528
In Commercial Distribution

  • 00690103032444 ()
  • 50690103032449 ()

  • 28 Fr. (9.3 mm) x 60 cm (24")
LV89528

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Venous Cannula
Edwards Lifesciences LLC
FEMII012V
Not in Commercial Distribution

  • 00690103031157 ()
  • 50690103031152 ()

  • 12 Fr. (4.0 mm) x 11.5 cm (4.5")
FEMII012V

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII012AT
Not in Commercial Distribution

  • 00690103031133 ()
  • 50690103031138 ()

  • 12 Fr. (4.0 mm) x 6.5 cm (2.6")
FEMII012AT

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII012A
Not in Commercial Distribution

  • 00690103031119 ()
  • 50690103031114 ()

  • 12 Fr. (4.0 mm) x 6.5 cm (2.6")
FEMII012A

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Venous Cannula
Edwards Lifesciences LLC
FEMII010V
Not in Commercial Distribution

  • 00690103031096 ()
  • 50690103031091 ()

  • 10 Fr. (3.3 mm) x 11.5 cm (4.5")
FEMII010V

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII010AT
Not in Commercial Distribution

  • 00690103031072 ()
  • 50690103031077 ()

  • 10 Fr. (3.3 mm) x 6.5 cm (2.6")
FEMII010AT

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII010A
Not in Commercial Distribution

  • 00690103031058 ()
  • 50690103031053 ()

  • 10 Fr. (3.3 mm) x 6.5 cm (2.6")
FEMII010A

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Venous Cannula
Edwards Lifesciences LLC
FEMII008V
Not in Commercial Distribution

  • 00690103031034 ()
  • 50690103031039 ()

  • 8 Fr. (2.7 mm) x 11.5 cm (4.5")
FEMII008V

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII008AT
Not in Commercial Distribution

  • 00690103031010 ()
  • 50690103031015 ()

  • 8 Fr. (2.7 mm) x 6.5 cm (2.6")
FEMII008AT

  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII008A
Not in Commercial Distribution

  • 00690103030990 ()
  • 50690103030995 ()

  • 8 Fr. (2.7 mm) x 6.5 cm (2.6")
FEMII008A

  • Cardiopulmonary bypass cannula, femoral
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