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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STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Contra Angle 70:1
Nouvag AG
5065NOU
In Commercial Distribution

  • ENOU5065NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 16:1 Endodontics
Nouvag AG
5061NOU
In Commercial Distribution

  • ENOU5061NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 8:1 Endodontics
Nouvag AG
5057NOU
In Commercial Distribution

  • ENOU5057NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 32:1
Nouvag AG
5054NOU
In Commercial Distribution

  • ENOU5054NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 20:1 LED
Nouvag AG
5052nou
In Commercial Distribution

  • ENOU5052NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5051NOU
In Commercial Distribution

  • ENOU5051NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5050NOU
In Commercial Distribution

  • ENOU5050NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Clip for Contra Angle
Nouvag AG
1881
In Commercial Distribution

  • ENOU18819 ()
  • ENOU18810 ()


  • Line-powered dental drilling/sawing system handpiece
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
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
CANNULA CB57414 FEM ART 14FR CARMEDA 10L
MEDTRONIC, INC.
CB57414
Not in Commercial Distribution

  • 00681490550406 ()

  • Catheter Gauge: 14.0 French


  • Cardiopulmonary bypass cannula, femoral
The reciprocating microsaw handpiece is intended to be used in oral and maxillofacial surgery for cutting bone and hard tissues.
Bien-Air Dental SA
1601098-001
In Commercial Distribution

  • J00716010980011 ()
1601098-001

  • Surgical power tool system handpiece, sawing, line-powered
CANN CB96428 FEM VEN 28FR 8L
MEDTRONIC, INC.
CB96428
Not in Commercial Distribution

  • 00643169263079 ()

  • Catheter Gauge: 28.0 French


  • Cardiopulmonary bypass cannula, femoral
METAL BRACKET ONLY FOR HANDPIECE HOLDER L/F
ACE SURGICAL SUPPLY CO., INC.
00320120
In Commercial Distribution

  • 00614950014217 ()
00320120

  • Dental power tool system handpiece, line-powered
THROTTLE LOCK DOWN STRAP FOR #0031717 & #0031720 FOOT PEDAL *AUTOCLAVABLE*
ACE SURGICAL SUPPLY CO., INC.
0031725
In Commercial Distribution

  • 00614950014200 ()
0031725

  • Dental power tool system handpiece, line-powered
No Description
BONART CO., LTD.
LCC-120A
In Commercial Distribution

  • 04719873120666 ()


  • Dental power tool system handpiece, line-powered
No Description
BONART CO., LTD.
LSC-101A
In Commercial Distribution

  • 04719873120215 ()


  • Dental power tool system handpiece, line-powered
CANNULA 96014 FEM 14ART 17VEN EA 17L
MEDTRONIC, INC.
96014
Not in Commercial Distribution

  • 00613994557100 ()

  • 14 FR Arterial
  • 17 FR Venous


  • Cardiopulmonary bypass cannula, femoral
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