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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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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
No Description
DIAGNOSTICA STAGO
00596
In Commercial Distribution

  • 03607450005967 ()


  • Antithrombin III (ATIII) IVD, kit, chromogenic
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
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
Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-1
In Commercial Distribution

  • 10858512007034 ()
  • 30858512007038 ()

  • Total Volume: 30 Milliliter
303-1

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-2
In Commercial Distribution

  • 30858512007014 ()
  • 10858512007010 ()

  • Total Volume: 20 Milliliter
301-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-1
In Commercial Distribution

  • 30858512007007 ()
  • 10858512007003 ()

  • Total Volume: 20 Milliliter
301-1

  • Multiple urine analyte IVD, control
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
Corrugated Tubing, Blue, Scored at 6 inch, 22 mm, 100 FT
Medi/Nuclear Corporation, Inc.
MN9680
In Commercial Distribution

  • 00857863007871 ()


  • Aerosol delivery tubing
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188502151 ()


  • Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
Well at Walgreens TRUE METRIX AIR self monitoring blood glucose meter
TRIVIDIA HEALTH, INC.
TRUE METRIX AIR self monitoring blood glucose meter
In Commercial Distribution

  • 10311917173891 ()
  • 00311917173894 ()
  • 00021292007720 ()
REA4001-01

  • Glucose monitoring system IVD, home-use
Hu Capsule Polisher Ring Tip Set at 90 Degrees, Round Handle
Med Saver, Inc.
5-1756
In Commercial Distribution

  • 00194613119300 ()


  • Ophthalmic surgical probe, reusable
Osteotome, angled, convex, 4.0 mm < 4.5 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
321.05
In Commercial Distribution

  • 00841685101091 ()


  • Dental osteotome
Osteotome, straight, convex, 4.5 mm < 5.0 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
320.06
In Commercial Distribution

  • 00841685101046 ()


  • Dental osteotome
Osteotome, straight, convex, 3.5 mm < 4.0 mm, Depth marks at: 8-10-12-15-16mm
A. TITAN INSTRUMENTS, INC.
320.04
In Commercial Distribution

  • 00841685101022 ()


  • Dental osteotome
30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
FOREMOUNT ENTERPRISE CO., LTD.
152102
In Commercial Distribution

  • 04719871894002 ()


  • Straight/elbow breathing circuit connector, single-use
Large Mayo Stand Cover ,62X27,Level 4,Yellow Bias at top
Lac-Mac Limited
075XX
In Commercial Distribution

  • 00627755250636 ()

  • Height: 27 Inch
  • Width: 62 Inch
075XX

  • Patient surgical drape, reusable
Oral Surgery Rongeur, #4A, 6 1/2", jaws at 35deg angle
Avalign Technologies, Inc.
1-22488
In Commercial Distribution

  • 00190776374518 ()


  • Dental rongeur
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8TH
In Commercial Distribution

  • 20817583023050 ()
  • 10817583023053 ()
  • 00817583023056 ()
MS-01J06-8TH

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8
In Commercial Distribution

  • 20817583023043 ()
  • 10817583023046 ()
  • 00817583023049 ()
MS-01J06-8

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01J06-4
In Commercial Distribution

  • 20817583023036 ()
  • 10817583023039 ()
  • 00817583023032 ()
MS-01J06-4

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01606-8
In Commercial Distribution

  • 20817583023012 ()
  • 10817583023015 ()
  • 00817583023018 ()
MS-01606-8

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01606-4
In Commercial Distribution

  • 20817583023005 ()
  • 10817583023008 ()
  • 00817583023001 ()
MS-01606-4

  • Surgical sleeve cover
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