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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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ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Shallow Curve, 10 Holes, 107mm, Ti
GLOBUS MEDICAL, INC.
1186.0160
In Commercial Distribution

  • 00889095954067 ()

  • Length: 107 Millimeter
  • Shallow Contour
  • 10 Shaft Holes
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Shallow Curve, 8 Holes, 87mm, Ti
GLOBUS MEDICAL, INC.
1186.0158
In Commercial Distribution

  • 00889095954043 ()

  • Length: 87 Millimeter
  • Centered at 42%
  • 8 Shaft Holes
  • Shallow Contour


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Shallow Curve, 6 Holes, 72mm, Ti
GLOBUS MEDICAL, INC.
1186.0156
In Commercial Distribution

  • 00889095954029 ()

  • Length: 72 Millimeter
  • Shallow Contour
  • Centered at 42%
  • 6 Shaft Holes


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Drews Irrigating Vectis 23ga with One Front Irrigating Port at 12 o'clock and Two Back Irrigating Ports at 10, 2 o'clock, 38mm Overall Length
Crestpoint Management Limited
CA765
In Commercial Distribution

  • G412CA7650 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Stainless Steel Cutting Block Template, 8CM Tall, 6cm Wide at Base, 10cm Wide at the Top, 3/8” Thick, Surgical Grade Autoclavable Stainless Steel
ELMED INCORPORATED
13-SSCB-W
In Commercial Distribution

  • 00198506058455 ()
13-SSCB-W

  • Dissection board
Stainless Steel Cutting Block Template, 8CM Tall, 5cm Wide at Base, 8cm Wide at the Top, 3/8” Thick, Surgical Grade Autoclavable Stainless Steel
ELMED INCORPORATED
13-SSCB-T
In Commercial Distribution

  • 00198506058448 ()
13-SSCB-T

  • Dissection board
Perpendicular Bypass, TCA Vitros 5.1 FS AT is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices.
Thermo Fisher Scientific Oy
1
In Commercial Distribution

  • 06438153000358 ()
952043

  • Specimen processing instrument IVD
No Description
DIAGNOSTICA STAGO
00596
In Commercial Distribution

  • 03607450005967 ()


  • Antithrombin III (ATIII) IVD, kit, chromogenic
The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
3059
In Commercial Distribution

  • 00050428526859 ()
  • 10050428526856 ()
3059

  • Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
3059
In Commercial Distribution

  • 00050428350423 ()
  • 10050428350420 ()
3059

  • Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3962-625
In Commercial Distribution

  • 04045396160668 ()
3962-625

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3961-625
In Commercial Distribution

  • 04045396160637 ()
3961-625

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3962-620
In Commercial Distribution

  • 04045396160651 ()
3962-620

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3961-630
In Commercial Distribution

  • 04045396160644 ()
3961-630

  • Surgical binoculars, reusable
Riester binocular loupes are used to enlarge the examination field.
Rudolf Riester GmbH
3960-630
In Commercial Distribution

  • 04045396160620 ()
3960-630

  • Surgical binoculars, reusable
QuickVue COVID-19 Test
DIAGNOSTIC HYBRIDS, INC.
20452
In Commercial Distribution

  • 30014613340188 ()
289586

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Graether Degree Gauge with four stabilizing blades at 0, 90, 180, & 270 degrees, (for use with the CM-0129 Graether Half Circle Axis Marker), degrees labeled at 30 degree increments with lines at every 10 degrees, Flat Handle, Stainless Steel
Crestpoint Management Limited
PH9512
In Commercial Distribution

  • G412PH95120 ()


  • Medical ruler, reusable
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Dynarex Corporation
33952
In Commercial Distribution

  • 00840117324008 ()
  • 00840117327498 ()


  • Medical device air compressor
Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Titanium
Crestpoint Management Limited
PH9517T
In Commercial Distribution

  • G412PH9517T0 ()


  • Corneal marker, reusable
Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-2
In Commercial Distribution

  • 30858512007045 ()
  • 10858512007041 ()

  • Total Volume: 30 Milliliter
303-2

  • Multiple urine analyte IVD, control
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