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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Cholangiography Fixation Clamp
Karl Storz GmbH & Co. KG
28378CH
In Commercial Distribution

  • 04048551234969 ()


  • Rigid endoscopic sponge/swab forceps
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
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
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
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
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
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
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
No Description
Société Chirurgicale Instrumentarium Inc
L.70.922
In Commercial Distribution

  • 00810055471713 ()


  • Frontal sinus file/rasp
MINI COMPRESSION DRIVER
Smith & Nephew, Inc.
211910
In Commercial Distribution

  • 00885556869017 ()
211910

  • Frontal sinus file/rasp
An imovifa is used to perform visual field testing by recording the patient's reaction to small light spots automatically displayed at various positions.
CREWT MEDICAL SYSTEMS, INC.
imovifa
In Commercial Distribution

  • 04573277310111 ()


  • Perimeter, automatic
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT. Color blue.
AED BATTERY EXCHANGE, LLC
9146-B-ABE
In Commercial Distribution

  • 00864312000246 ()


  • Primary battery
At home IVD LH tests (also called ovulation tests or OPKs) measure luteinizing hormone before ovulation to identify your two most fertile days.
Mfb Fertility, Inc.
Predict
In Commercial Distribution

  • 00850035206102 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2111-20-046-NS
In Commercial Distribution

  • 00650551088233 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-20-046-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2111-20-046
In Commercial Distribution

  • 00650551063667 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-20-046

  • Cortical electrode
Bankart Kolbel Glenoid Retractor Strongly Curved Overall Length 11 3/4" (300mm) With 23mm Wide Blade With 2 Prongs At End Of Retractor
Med Saver, Inc.
75-5271-33L
In Commercial Distribution

  • 00194613065447 ()


  • Hand-held surgical retractor, reusable
Bankart Kolbel Glenoid Retractor Strongly Curved Overall Length 11 3/4" (300mm) With 15mm Wide Blade With 2 Prongs At End Of Retractor
Med Saver, Inc.
75-5271-32L
In Commercial Distribution

  • 00194613065430 ()


  • Hand-held surgical retractor, reusable
Bacterial: 99.998%, Viral: 99.96%, Adult/Ped : Tidal Volume Range(150-1500mL), Breathing Resistance(1.4cm H2O at 60 L/min), Dead Space(45mL), Weight(21g)
Dynarex Corporation
30400
In Commercial Distribution

  • 00840117305878 ()
  • 00840117305861 ()


  • Heat/moisture exchanger insertable filter
Adult, Tidal Volume Range(150-1500mL), Media(Foam), Dead Space(62 (34)mL), Breathing Resistance(3.0cm H2O at 60 L/min), Weight(24g), Adult
Dynarex Corporation
30204
In Commercial Distribution

  • 00840117305465 ()
  • 00840117305458 ()


  • Heat/moisture exchanger/microbial medical gas filter
Adult, Tidal Volume Range(250-1500mL), Media(Foam + Flat Media), Dead Space(89 (60)mL, Breathing Resistance(2.0cm H2O at 60L /min), Weight (45g)
Dynarex Corporation
30106
In Commercial Distribution

  • 00840117305366 ()
  • 00840117305359 ()


  • Heat/moisture exchanger/microbial medical gas filter
Whitehouse Gravity Axis Marker, Straight, Marks at 3, 6, 9 o'clock, 11.00/14.00 mm, Length 152 mm, Titanium Handle, Stainless Steel Gravity System
RUMEX INTERNATIONAL CORP.
3-1931
In Commercial Distribution

  • 00840159904008 ()
3-1931

  • Corneal marker, reusable
Whitehouse Gravity Axis Marker, Angled, Marks At 3, 6, 9 o'clock, 11.00/14.00mm, Length 153 mm, Round Titanium Handle, Stainless Steel Gravity System
RUMEX INTERNATIONAL CORP.
3-193
In Commercial Distribution

  • 00840159900666 ()
3-193

  • Corneal marker, reusable
LRI diamond knife, straight, 1.00mm wide, 20° trifacet blade, 0.20mm truncated tip, dull sides, single footplate, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI diamond knife
In Commercial Distribution

  • 00190660203382 ()
27-643E

  • Ophthalmic knife, reusable
Gimbel irrigating cannula, 30 gauge, straight, U-shaped tip for cortex removal at the 12 o'clock position, front opening, 28.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Gimbel irrigating cannula
In Commercial Distribution

  • 00190660004279 ()
1419E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Drews capsule polisher cannula, 25 gauge, angled, 2.5mm posterior sandblasted ring tip, 0.2mm irrigating port at 6 o'clock, 23.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Drews capsule polisher cannula
In Commercial Distribution

  • 00190660003814 ()
1135E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Castroviejo colibri corneal forceps, 4 1/4'', 0.12mm 1x2 teeth set at 45 degrees, 6.0mm TC dusted tying platforms, wide flat handle, titanium
AMBLER SURGICAL CORP.
Castroviejo colibri corneal forceps
In Commercial Distribution

  • 00190660042912 ()
2234T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
LRI economy triple-edge diamond knife, straight, 1.00mm wide, 0.20mm truncated tip, sharp sides, single footplate, preset at 550 microns, short j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI economy triple-edge diamond knife
In Commercial Distribution

  • 00190660029005 ()
21-239E

  • Ophthalmic knife, reusable
LRI economy diamond knife, straight, 1.00mm wide, 30 degrees lance blade, dull sides, single footplate, preset at 600 microns, short j-slot aluminum handle
AMBLER SURGICAL CORP.
LRI economy diamond knife
In Commercial Distribution

  • 00190660028985 ()
21-235E

  • Ophthalmic knife, reusable
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 9.8 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 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 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
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