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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CIN Agar, 15x100 monoplate, 10/pk (Cefsulodin, Irgasan, Novobiocin) For the selective isolation of Yersinia enterocolitica and Aeromonas spp. Inoculate at room temperature.
HARDY DIAGNOSTICS
G220
Not in Commercial Distribution

  • 00816576025404 ()
  • 00816576025411 ()
G220

  • Differential/selective agar culture medium IVD
Dialysate Additive 9.7 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 3.785 liters of concentrate proportioned at 1:34
DIASOL, INC.
CC9.7
In Commercial Distribution

  • B467CC97145 ()
  • B467CC97 ()

  • Weight: 9.7 Gram
CC6

  • Haemodialysis concentrate
Dialysate Additive 3.1 grams Calcium Chloride increases Calcium by 0.25 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC3.1
In Commercial Distribution

  • B467CC31170 ()
  • B467CC31 ()

  • Weight: 3.1 Gram
CC1

  • Haemodialysis concentrate
Dialysate Additive 12.5 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC12.5
In Commercial Distribution

  • B467CC125120 ()
  • B467CC125 ()

  • Weight: 12.5 Gram
CC9

  • Haemodialysis concentrate
Dialysate Additive 9.8 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:34
DIASOL, INC.
PC9.8
In Commercial Distribution

  • B467PC98145 ()
  • B467PC98 ()

  • Weight: 9.8 Gram
PC19

  • Haemodialysis concentrate
Dialysate Additive 6.3 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC6.3
In Commercial Distribution

  • B467PC63170 ()
  • B467PC63 ()

  • Weight: 6.3 Gram
PC18

  • Haemodialysis concentrate
Dialysate Additive 5.8 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC5.8
In Commercial Distribution

  • B467PC58170 ()
  • B467PC58 ()

  • Weight: 5.8 Gram
PC17

  • Haemodialysis concentrate
Dialysate Additive 15.9 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC15.9
In Commercial Distribution

  • B467PC159145 ()
  • B467PC159 ()

  • Weight: 15.9 Gram
PC16

  • Haemodialysis concentrate
Dialysate Additive 12.7 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC12.7
In Commercial Distribution

  • B467PC127120 ()
  • B467PC127 ()

  • Weight: 12.7 Gram
PC15

  • Haemodialysis concentrate
Dialysate Additive 11.5 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC11.5
In Commercial Distribution

  • B467PC115145 ()
  • B467PC115 ()

  • Weight: 11.5 Gram
PC13

  • Haemodialysis concentrate
Dialysate Additive 8.6 grams Magnesium Chloride increases Magnesium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
MGC8.6
In Commercial Distribution

  • B467MG86 ()
  • B467MG86140 ()

  • Weight: 8.6 Gram
MGC22

  • Haemodialysis concentrate
Dialysate Additive 6.3 grams Calcium Chloride to increase Calcium by 0.5mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC6.3
In Commercial Distribution

  • B467CC63170 ()
  • B467CC63 ()

  • Weight: 6.3 Gram
CC4

  • Haemodialysis concentrate
Dialysate Additive 5.7 grams Calcium Chloride increases Calcium by 0.5 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC5.7
In Commercial Distribution

  • B467CC57170 ()
  • B467CC57 ()

  • Weight: 5.7 Gram
CC3

  • Haemodialysis concentrate
Dialysate Additive 31.3 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC31.3
In Commercial Distribution

  • B467CC313115 ()
  • B467CC313 ()

  • Weight: 31.3 Gram
CC11

  • Haemodialysis concentrate
Dialysate Additive 11.3 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC11.3
In Commercial Distribution

  • B467CC113145 ()
  • B467CC113 ()

  • Weight: 11.3 Gram
CC8

  • Haemodialysis concentrate
Dialysate Additive 10.2 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
CC10.2
In Commercial Distribution

  • B467CC102145 ()
  • B467CC102 ()

  • Weight: 10.2 Gram
CC7

  • Haemodialysis concentrate
Henderson Style Pre-Op Reference Marker, Half Circle With 3 Blunt Alignment Pins At 0, 90 and 180 Degrees, with Round Knurled Handle, Titanium
Surgical Direct, Inc.
S34016.200T
In Commercial Distribution

  • B382S34016200T0 ()
S34016.200T

  • Intraocular retractor, reusable
Diamatrix Custom McIntyre Anterior Chamber Cannula, 26 Gauge, Blunt tip, Angled 12mm from bend to tip, 18mm tip length. Textured at Tip 1mm
Diamatrix
C523-26.1
In Commercial Distribution

  • 00813059016287 ()
C523-26.1

  • Ocular hook/spatula/manipulator, reusable
Infrared and near infrared phototherapy device emitting up to 30 W at 810nm, 915nm, 940nm, 980nm, 650nm, 10.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix3000U5
In Commercial Distribution

  • 06976487170090 ()


  • Musculoskeletal/physical therapy laser, professional
9.5F PLASTIC DIGNITY®DUAL CT PORT W/ATTACHABLECT PORT W/AT CHRONOFLEX®POLYURETHANE CATHETER W/5F MICRO-STICK® INTRODUCER SETINTRODUCER SET
Medical Components, Inc.
MICTI95002
Not in Commercial Distribution

  • 50884908103637 ()
  • 00884908103632 ()
MICTI95002

  • Vascular port/catheter
The Infrared non-contact Thermometer is intended to measurement forehead temperature at home or hospital, for patients of all ages by Infrared sensing probe.
Dongguan HCS Electronics Co., Ltd.
HET-R121
In Commercial Distribution

  • 06971463320032 ()


  • Infrared patient thermometer, skin
Frontal Sinus Rasp by Wigand slender pattern Ø 2.5 mm
FENTEX medical GmbH
418211FX
In Commercial Distribution

  • 04250407733872 ()
418211FX

  • Frontal sinus file/rasp
Frontal Sinus Rasp by Wigand strong pattern Ø 3 mm
FENTEX medical GmbH
418210FX
In Commercial Distribution

  • 04250407733865 ()
418210FX

  • Frontal sinus file/rasp
Antrum Rasp by Watson-Williams slightly curved, blunt 23 cm
FENTEX medical GmbH
408600FX
In Commercial Distribution

  • 04250407733063 ()
408600FX

  • Frontal sinus file/rasp
Legueu Bladder Spatula 26.0cm
RZ-Medizintechnik GmbH
320-170-260
In Commercial Distribution

  • 04049197263863 ()
320-170-260

  • Bladder spatula
Kocher Bladder Spatula 23.5cm
RZ-Medizintechnik GmbH
320-175-235
In Commercial Distribution

  • 04049197263870 ()
320-175-235

  • Bladder spatula
Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Large, 5mm Wide, Blunt Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
400237
In Commercial Distribution

  • M2744002371 ()
  • 10381780190981 ()

  • Width: 5 Millimeter
  • 7-3/4"
400-237

  • Frontal sinus file/rasp
Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Large, 5mm Wide, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
400236
In Commercial Distribution

  • M2744002361 ()
  • 10381780190974 ()

  • Width: 5 Millimeter
  • 7-3/4"
400-236

  • Frontal sinus file/rasp
Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Medium, 4mm Wide, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
400235
In Commercial Distribution

  • M2744002351 ()
  • 10381780190967 ()

  • Width: 4 Millimeter
  • 7-3/4"
400-235

  • Frontal sinus file/rasp
Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Small, 3mm Wide, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
400234
In Commercial Distribution

  • M2744002341 ()
  • 10381780190950 ()

  • 7-3/4"
  • Width: 3 Millimeter
400-234

  • Frontal sinus file/rasp
FORCEPS 7762A-5 45DEG W/SUCT KLOS CUP
INTEGRA MICROFRANCE
7762A-5
In Commercial Distribution

  • 10381780088905 ()
7762A-5

  • Frontal sinus file/rasp
FORCEPS 7762-5 STR W/SUCT KLOSSEK CUP
INTEGRA MICROFRANCE
7762-5
In Commercial Distribution

  • 10381780088875 ()
7762-5

  • Frontal sinus file/rasp
FORCEPS 7762A-5 45DEG W/SUCT KLOS CUP
INTEGRA MICROFRANCE
7762A-5
In Commercial Distribution

7762A-5

  • Frontal sinus file/rasp
FORCEPS 7762-5 STR W/SUCT KLOSSEK CUP
INTEGRA MICROFRANCE
7762-5
In Commercial Distribution

7762-5

  • Frontal sinus file/rasp
Integra® Miltex® Wiener Antrum Rasp, No. 3, Large, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-382
In Commercial Distribution

  • H834203820 ()
  • 10381780421870 ()

  • 7-3/4"
  • Width: 5 Millimeter
20-382

  • Frontal sinus file/rasp
Integra® Miltex® Wiener Antrum Rasp, No. 2, Medium, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-380
In Commercial Distribution

  • H834203800 ()
  • 10381780421863 ()

  • Width: 4 Millimeter
  • 7-3/4"
20-380

  • Frontal sinus file/rasp
Integra® Miltex® Wiener Antrum Rasp, No. 1, Small, Trocar Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
20-378
In Commercial Distribution

  • H834203780 ()
  • 10381780421856 ()

  • 7-3/4"
  • Width: 3 Millimeter
20-378

  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.724
In Commercial Distribution

  • 00810055472222 ()


  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.090
In Commercial Distribution

  • 00810055472048 ()


  • Frontal sinus file/rasp
No Description
Société Chirurgicale Instrumentarium Inc
s.50.055
In Commercial Distribution

  • 00810055472031 ()


  • Frontal sinus file/rasp
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