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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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R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 66/70MM
Smith & Nephew, Inc.
71934558
In Commercial Distribution

  • 00885556192030 ()
71934558

  • Ceramic acetabular liner
TRIAL REFLECTION LINER XLPE 36 ID 20 DEG ANT +6 50-52 E
Smith & Nephew, Inc.
71934295
In Commercial Distribution

  • 00885556143087 ()
71934295

  • General internal orthopaedic fixation system implantation kit
TRIAL REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 58-60 G
Smith & Nephew, Inc.
71934296
In Commercial Distribution

  • 00885556143070 ()
71934296

  • General internal orthopaedic fixation system implantation kit
TRIAL REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 62-64 H
Smith & Nephew, Inc.
71934297
In Commercial Distribution

  • 00885556143063 ()
71934297

  • General internal orthopaedic fixation system implantation kit
ESOPHAGOSCOPE-TUBE ID 4.4MM OD 5.7mm, TL 200mm, with proximal light connection, reusable
Richard Wolf GmbH
827040
Not in Commercial Distribution

  • 04055207009536 ()

  • Lumen/Inner Diameter: 4.4 Millimeter
8270.40

  • Rigid optical oesophagoscope
VACUUM TUBING, 4PK, 5/8"OD x 3/8"ID x 3FT
Microaire Surgical Instruments LLC
ASP-TUBING
In Commercial Distribution

  • 00847399018960 ()

  • Outer Diameter: 0.625 Inch
  • Lumen/Inner Diameter: 0.375 Inch
  • Length: 3 Feet


  • Methoxyflurane anaesthesia vaporizer
The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection tag, or the lot or batch number of a reagent.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
HistoCore PELORIS 3 Barcode Scanner Kit
In Commercial Distribution

  • 09349458005566 ()
S45.4508

  • Tissue processor IVD, automated/semi-automated
Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use.
Alere Scarborough, Inc.
192-080
In Commercial Distribution

  • 00811877011361 ()


  • SARS-CoV-2 nucleic acid IVD, control
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
No Description
I.T.S. GmbH
36851
In Commercial Distribution

  • 09120069818086 ()


  • Orthopaedic bone washer, sterile
GC Tri Plaque ID Gel™ 40g tube (36 mL, approximately 130 applications)
Gc America Inc.
004273
Not in Commercial Distribution

  • D0470042731 ()

  • Weight: 40 Gram
004273

  • Dental caries detecting stain
BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 Rotaflow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Temperature Probe.
DATASCOPE CORP.
BEQ-TOP 54501
Not in Commercial Distribution

  • 00607567213364 ()
709000498R01

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 800ml, BMU Cell Ven. 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o vent Porous Media 3/8x3/8, Temperature Probe,
DATASCOPE CORP.
BEQ-T 37313
In Commercial Distribution

  • 00607567213302 ()
709000606

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000ml - 2 spike ports, BEQ-RF32 Rotaflow, CDI Sat Cell 3/8" Systems 100, Blood Microfilter Systems SQ 40 S, prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 5900
In Commercial Distribution

  • 00607567212275 ()
701050228R01

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S,Gas Filter
DATASCOPE CORP.
BEQ-TOP 38300
In Commercial Distribution

  • 00607567212060 ()
701055862R01

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BEQ-T 44802
Not in Commercial Distribution

  • 00607567211353 ()
709000394

  • Cardiopulmonary bypass system blood tubing set
BO-HMOD 70000-USA Adult Quadrox iD, BO-VHK 31000 Venous Res. Pediatric (MACE), BO-RF32 RotaFlow, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-TOP 26403
Not in Commercial Distribution

  • 00607567210585 ()
709000308

  • Cardiopulmonary bypass system blood tubing set
BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-T 21902
Not in Commercial Distribution

  • 00607567203341 ()
701055521

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 8101
Not in Commercial Distribution

  • 00607567201095 ()
701049524

  • Cardiopulmonary bypass system blood tubing set
Clean-Bor Tube
Vacumed
1013-60-BULK
In Commercial Distribution

  • 00850644007916 ()
  • 08506440079160 ()
1013-60-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-60
In Commercial Distribution

  • 00850644007909 ()
1013-60

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-48-BULK
In Commercial Distribution

  • 00850644007893 ()
  • 08506440078934 ()
1013-48-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-48
In Commercial Distribution

  • 00850644007886 ()
1013-48

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-39-BULK
In Commercial Distribution

  • 00850644007879 ()
  • 08506440078798 ()
1013-39-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-39
In Commercial Distribution

  • 00850644007862 ()
1013-39

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-24-BULK
In Commercial Distribution

  • 00850644007855 ()
  • 08506440078552 ()
1013-24-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1013-24
In Commercial Distribution

  • 00850644007848 ()
1013-24

  • Gas-sampling/monitoring respiratory tubing, single-use
The Accelerate PhenoTest™ BC ID QC test is intended to serve as an external quality control to monitor the accuracy of the organism identification calls made by the Accelerate PhenoTest™ BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest™ BC AST QC test and Accelerate PhenoTest™ BC kit.
ACCELERATE DIAGNOSTICS, INC.
10105158
In Commercial Distribution

  • 10862011000335 ()
  • 00862011000338 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Sarstedt Aktiengesellschaft & Co.KG
90.2060.086
In Commercial Distribution

  • 04038917792790 ()
90.2060.086

  • Laboratory container/microscope slide robotic transfer system IVD
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