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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Kleegman Dilator 10-3/4" (26.9cm), 1-3mm at tips, double ended
Hayden Medical, Inc.
290-003
In Commercial Distribution

  • 00840319708279 ()
290-003

  • Fixed-diameter cervical dilator, reusable
Capillary tube, EDTA, 75mm, marked at: 32mm & 64mm, 100/vial
GLOBE SCIENTIFIC INC.
164113
In Commercial Distribution

  • 00840095604369 ()
  • 00840095610650 ()


  • Capillary blood transfer tube IVD, EDTA
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
Eye protection (LOEWY 004.0) against laser light at 810 nm
LAMBDA SPA
Protective eye wear
In Commercial Distribution

  • 08056093611106 ()
LOEYW004.0

  • Laser beam eye protector, patient
  • Laser beam eye protector, staff
Prostate Biopsy Transport Kit, University of Alabama at Birmingham Only
AERO-MED, LLC
CA16325
In Commercial Distribution

  • 50885380159242 ()
  • 10885380159244 ()
CA16325

  • Blood/tissue storage/culture container
Well at Walgreens TRUE METRIX self monitoring blood glucose meter
TRIVIDIA HEALTH, INC.
TRUE METRIX self monitoring blood glucose meter
In Commercial Distribution

  • 10311917166893 ()
  • 00311917166896 ()
  • 00021292007690 ()
RE4001-01

  • Glucose monitoring system IVD, home-use
BARR FISTULA PROBE STERLING SILVER SHAFT WITH EYE AT TIP
SONTEC INSTRUMENTS, INC.
508-542
In Commercial Distribution

  • 00192896044616 ()

  • Length: 11 Inch
508-542

  • Gastro-urological director
45°, 2.5 mm, 13 cm, Luer-Lock suction at the outside
Spiggle & Theis Medizintechnik GmbH
30-1844
In Commercial Distribution

  • 04250676734723 ()
30-1844

  • ENT suction dissector
45°, 2 mm 13 cm, Luer-Lock suction at the outside
Spiggle & Theis Medizintechnik GmbH
30-1840
In Commercial Distribution

  • 04250676734709 ()
30-1840

  • ENT suction dissector
45°, 2 mm 13 cm, Luer-Lock suction at the outside
Spiggle & Theis Medizintechnik GmbH
10-809-12
In Commercial Distribution

  • 04250676700858 ()
10-809-12

  • ENT suction dissector
45°, 2.5 mm, 13 cm, Luer-Lock suction at the outside
Spiggle & Theis Medizintechnik GmbH
10-811-12
In Commercial Distribution

  • 04250676702418 ()
10-811-12

  • ENT suction dissector
Copper Sulfate, 1.055 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2340-32
In Commercial Distribution

  • 00192024025746 ()
2340

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.053 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2330-16
In Commercial Distribution

  • 00192024025722 ()
2330

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.053 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2330-1
In Commercial Distribution

  • 00192024025715 ()
2330

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.053 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2330-5
In Commercial Distribution

  • 00192024025708 ()
2330

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.053 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2330-32
In Commercial Distribution

  • 00192024025692 ()
2330

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.054 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
R2331500-500C
In Commercial Distribution

  • 00192024165244 ()
R2331500

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.055 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2340-16
In Commercial Distribution

  • 00192024025777 ()
2340

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.055 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2340-1
In Commercial Distribution

  • 00192024025760 ()
2340

  • Copper sulfate solution IVD, reagent
Copper Sulfate, 1.055 Specific Gravity at 25°C (77°F)
Ricca Chemical Company, LLC
2340-5
In Commercial Distribution

  • 00192024025753 ()
2340

  • Copper sulfate solution IVD, reagent
SaliPen is an electrostimulating device aimed at treating dry mouth.
SALIWELL LTD
OTC
In Commercial Distribution

  • 07290014891005 ()


  • Dry mouth saliva electrical stimulator
Table Shield Left. To be placed at 1st operator position.
Texray AB
Table Shield Left
In Commercial Distribution

  • 07350121950542 ()

  • Width: 90 Centimeter
  • Length: 100 Centimeter
TS1050

  • Radiation shielding table drape
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
Irrigating Cystotome, Straight, Angled at 55 Degrees, 25ga,-5/8"
Med Saver, Inc.
CA5020-SP
In Commercial Distribution

  • 00194613002060 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
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, 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 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
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
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
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
QuickVue COVID-19 Test
DIAGNOSTIC HYBRIDS, INC.
20452
In Commercial Distribution

  • 30014613340188 ()
289586

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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
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
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
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