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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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WVN CATH 007550 10PK 5423S 8 80 SONESCR
MEDTRONIC, INC.
007550
Not in Commercial Distribution

  • 20613994963899 ()
  • 00613994963895 ()

  • Lumen/Inner Diameter: 1.27 Millimeter
  • Catheter Gauge: 8.0 French
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use
WVN CATH 008973 10PK SONES 8F HI FLOW
MEDTRONIC, INC.
008973
Not in Commercial Distribution

  • 20613994963868 ()
  • 00613994963864 ()

  • Lumen/Inner Diameter: 1.473 Millimeter
  • Length: 100.0 Centimeter
  • Catheter Gauge: 8.0 French


  • Angiographic catheter, single-use
WVN CATH 008719 10PK 8F SONES B HIFLO 80
MEDTRONIC, INC.
008719
Not in Commercial Distribution

  • 20613994963806 ()
  • 00613994963802 ()

  • Lumen/Inner Diameter: 1.473 Millimeter
  • Catheter Gauge: 8.0 French
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use
CATHETER 008554 WVN 7.5F SONES B 100CM
MEDTRONIC, INC.
008554
Not in Commercial Distribution

  • 20613994963783 ()
  • 00613994963789 ()

  • Catheter Gauge: 7.5 French
  • Length: 100.0 Centimeter
  • Lumen/Inner Diameter: 1.245 Millimeter


  • Angiographic catheter, single-use
CATHETER 008553 WVN 7.5F SONES B 80CM
MEDTRONIC, INC.
008553
Not in Commercial Distribution

  • 20613994963776 ()
  • 00613994963772 ()

  • Catheter Gauge: 7.5 French
  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use
WVN CATH 007548 10PK 5423S 7 100 SONESCR
MEDTRONIC, INC.
007548
Not in Commercial Distribution

  • 20613994964827 ()
  • 00613994964823 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 100.0 Centimeter
  • Catheter Gauge: 7.0 French


  • Angiographic catheter, single-use
3100A/B BELLOWS / WATER TRAP
VYAIRE MEDICAL, INC.
766897
In Commercial Distribution

  • 10190752148840 ()
766897

  • Stationary electric high-frequency ventilator
No Description
NAKANISHI INC.
Perio Kit B
Not in Commercial Distribution

  • 04560264562660 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
KITAZATO CORPORATION
Cryotop US(B)
In Commercial Distribution

  • 14582231462923 ()
  • 04582231462926 ()
81174

  • Assisted reproduction vitrification carrier
Lancing Device
BIOTEST MEDICAL CORPORATION
8228
In Commercial Distribution

  • 04719871820049 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-5410D
In Commercial Distribution

  • 00811403015887 ()


  • Multiple electrolyte IVD, calibrator
To provide calibration points for the Na, K & Cl electrodes for AVL 982, 983 Analyzers.
Diamond Diagnostics Inc.
AV-BP0442D
In Commercial Distribution

  • 00811403010172 ()


  • Multiple electrolyte IVD, calibrator
No.
Dreve Otoplastik GmbH
0816
In Commercial Distribution

  • E23908161 ()
0816

  • Earmould, custom-made
No.
Dreve Otoplastik GmbH
0815
In Commercial Distribution

  • E23908151 ()
0815

  • Earmould, custom-made
No.
Dreve Otoplastik GmbH
0814
In Commercial Distribution

  • E23908141 ()
0814

  • Earmould, custom-made
No.
Dreve Otoplastik GmbH
0813
In Commercial Distribution

  • E23908131 ()
0813

  • Earmould, custom-made
No.
Dreve Otoplastik GmbH
0812
In Commercial Distribution

  • E23908121 ()
0812

  • Earmould, custom-made
No.
Dreve Otoplastik GmbH
0811
In Commercial Distribution

  • E23908111 ()
0811

  • Earmould, custom-made
CHANG Medium Basal. 90mL bottle.
IRVINE SCIENTIFIC, LLC
C100-90ML
In Commercial Distribution

  • 00810195240606 ()
C100

  • Cell culture medium IVD
No Description
BIOGENEX LABORATORIES
AM238-5M
In Commercial Distribution

  • 00810119670281 ()

  • Total Volume: 6 Milliliter
AM238-5M

  • CD20 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU238A-5UC
In Commercial Distribution

  • 00810119674203 ()

  • Total Volume: 0.5 Milliliter
MU238A-5UC

  • CD20 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM238-10M
In Commercial Distribution

  • 00810119676900 ()

  • Total Volume: 10 Milliliter
AM238-10M

  • CD20 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU238A-UC
In Commercial Distribution

  • 00810119675118 ()

  • Total Volume: 1 Milliliter
MU238A-UC

  • CD20 cell marker IVD, antibody
Scanned diode laser 808 nm for hair reduction
GME German Medical Engineering GmbH
1042
In Commercial Distribution

  • B12510420 ()
1042

  • Dermatological diode laser system
No Description
Sonova AG
US EPS
In Commercial Distribution

  • 07613389763997 ()
075-0065-11067

  • Noninvasive device battery charger
No Description
Sonova AG
no EPS
In Commercial Distribution

  • 07613389749663 ()
075-0065-10067

  • Noninvasive device battery charger
No Description
Sonova AG
EU EPS
In Commercial Distribution

  • 07613389746846 ()
075-0065-12067

  • Noninvasive device battery charger
Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.
Derma Sciences Canada Inc
SPD-24
In Commercial Distribution

  • 30381780491846 ()
  • 10381780491842 ()

  • 4 in X 8 in
  • 10 cm x 20 cm
DERMA-SPD24

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.
Derma Sciences Canada Inc
SPD-21
In Commercial Distribution

  • 30381780491839 ()
  • 10381780491835 ()

  • 4 in X 4 in
  • 10 cm x 10 cm
DERMA-SPD21

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6.
Derma Sciences Canada Inc
SPD-20
In Commercial Distribution

  • 30381780491822 ()
  • 10381780491828 ()

  • 5.1 cm x 5.1 cm
  • 2 in X 2 in
DERMA-SPD20

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Diabetic, Venous Stasis), and Stage I-IV Pressure Sores
Derma Sciences Canada Inc
SPD-03
In Commercial Distribution

  • 30381780491815 ()
  • 10381780491811 ()

  • 3 oz
  • 85 g
DERMA-SPD03

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Dalbo®-B Female part E
Cendres+Métaux SA
051511
In Commercial Distribution

  • 07640166513995 ()
051511

  • Dental anchor
Dalbo®-B Male part E
Cendres+Métaux SA
050423
In Commercial Distribution

  • 07640166513773 ()
050423

  • Dental anchor
The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
SenTec AG
PSG Cable B
In Commercial Distribution

  • 07640121880629 ()


  • Pulse Co-oximeter probe, reusable
  • Transcutaneous blood gas monitor sensor
  • Transcutaneous blood gas monitoring system
PFT Kit B, 35mm Pulmonary Function Kit - Case
A-M SYSTEMS, LLC
PFT Kit B - 180052
In Commercial Distribution

  • 00817081021233 ()
  • 00817081021226 ()
  • 00817081021578 ()
180052

  • Pulmonary function testing kit
Ultrasonic Generator replacement for Generator BoneWelder 150-W1
Surgical Fusion Technologies GmbH
SupraFuser B Generator
Not in Commercial Distribution

  • 07649990202204 ()
SF04-005-B

  • Ultrasonic surgical system generator
Temporary Material
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
591577AN
Not in Commercial Distribution

  • DVIV591577AN1 ()
591577AN

  • Temporary dental crown/bridge resin
Positive Control for Solidscreen II on TANGO instruments; 4ml
Bio-Rad Medical Diagnostics GmbH
806519100
In Commercial Distribution

  • 07611969951468 ()
806519100

  • Anti-Rh(D) antibody screen IVD, control
Contains VT601US(ES,VS×2), 4 of cryotopUSs(Blue)and Repro Plate
KITAZATO CORPORATION
VT601US-TOP(B)
In Commercial Distribution

  • 24582231462647 ()
  • 14582231462596 ()


  • IVF medium kit
Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A and B on the surface of human red blood cells by manual tube method.
DIAGAST
210522
In Commercial Distribution

  • 23661562105223 ()
  • 13661562105226 ()
210522

  • Anti-AB red blood cell grouping IVD, antibody
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