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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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Long Curette #3 1/2 Teeth LAT RIGHT at 50mm
Life Instrument Corporation
710-1535-3TC
In Commercial Distribution

  • M93071015353TC0 ()
71015353TC

  • Bone curette, reusable
American Rainbow Curette#2 Ang 90deg at 2mm from Cup
Life Instrument Corporation
712-0102-1-3-90
In Commercial Distribution

  • M930712010213900 ()


  • Bone curette, reusable
American Rainbow Curette#0 Ang 90deg at 2mm from Cup
Life Instrument Corporation
712-0100-1-3-90
In Commercial Distribution

  • M930712010013900 ()


  • Bone curette, reusable
Inamura Capsulorrhexis Fcps, 8.5mm with Marks at 2.5mm and 5mm
AURORA SURGICAL, LLC
AS7-133T
In Commercial Distribution

  • 08175700122900 ()
AS7-133T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Compressor / Nebulizer with disposable - Private Label Theda Care at Home
DEVILBISS HEALTHCARE LLC
3655LTPL-THED
Not in Commercial Distribution

  • 10885304001048 ()
  • 00885304001041 ()
3655LTPL-THED

  • Medical device air compressor
Toric IOL Reference Marker Blades are positioned at 0°, 90°, 180°, Head is angled at 70°, Diamond knurled handle, 98mm total length, Stainless
Diamatrix
M55S
In Commercial Distribution

  • 00813059016409 ()
M55S

  • Corneal marker, reusable
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Deep Curve, 6 Holes, 70mm, SS
GLOBUS MEDICAL, INC.
2186.0176
In Commercial Distribution

  • 00889095959390 ()

  • Length: 70 Millimeter
  • Deep Contour
  • 6 Shaft Holes
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Deep Curve, 8 Holes, 85mm, Ti
GLOBUS MEDICAL, INC.
1186.0178
In Commercial Distribution

  • 00889095954098 ()

  • Centered at 42%
  • Length: 85 Millimeter
  • Deep Contour
  • 8 Shaft Holes


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Deep Curve, 6 Holes, 70mm, Ti
GLOBUS MEDICAL, INC.
1186.0176
In Commercial Distribution

  • 00889095954074 ()

  • Deep Contour
  • 6 Shaft Holes
  • Length: 70 Millimeter
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Deep Curve, 10 Holes, 104mm, SS
GLOBUS MEDICAL, INC.
2186.0180
In Commercial Distribution

  • 00889095959437 ()

  • Deep Contour
  • 10 Shaft Holes
  • Length: 104 Millimeter
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Deep Curve, 8 Holes, 85mm, SS
GLOBUS MEDICAL, INC.
2186.0178
In Commercial Distribution

  • 00889095959413 ()

  • 8 Shaft Holes
  • Centered at 42%
  • Length: 85 Millimeter
  • Deep Contour


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Shallow Curve, 10 Holes, 107mm, SS
GLOBUS MEDICAL, INC.
2186.0160
In Commercial Distribution

  • 00889095959383 ()

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


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Shallow Curve, 8 Holes, 87mm, SS
GLOBUS MEDICAL, INC.
2186.0158
In Commercial Distribution

  • 00889095959369 ()

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


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 SS Anterior Clavicle Plate, Shallow Curve, 6 Holes, 72mm, SS
GLOBUS MEDICAL, INC.
2186.0156
In Commercial Distribution

  • 00889095959345 ()

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


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ANTHEM MIDSHAFT42 Anterior Clavicle Plate, Deep Curve, 10 Holes, 104mm, Ti
GLOBUS MEDICAL, INC.
1186.0180
In Commercial Distribution

  • 00889095954111 ()

  • Length: 104 Millimeter
  • Centered at 42%
  • 10 Shaft Holes
  • Deep Contour


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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
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
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
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
3961-625
In Commercial Distribution

  • 04045396160637 ()
3961-625

  • 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
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
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
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

  • 00050428350423 ()
  • 10050428350420 ()
3059

  • Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
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