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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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HACH - 00851575007242

MONTHLY MAINTENANCE KIT, CM130
HACH COMPANY
9717300
In Commercial Distribution

  • 00851575007242 ()
9717300

  • Haemodialysis system chlorine monitor

Calibra® Bio Bioceramic Luting Cement - D0026076081

Calibra® Bio Capsule Sample
DENTSPLY INTERNATIONAL INC.
607608
In Commercial Distribution

  • D0026076080 ()
  • D0026076081 ()

  • 3 Capsules
607608

  • Dental composite resin

Calibra® Bio - D0026076001

Calibra® Bio Evaluator Kit
DENTSPLY INTERNATIONAL INC.
607600
In Commercial Distribution

  • D0026076000 ()
  • D0026076001 ()

  • 5 Capsules, 1 Capsule Extruder
607600

  • Glass ionomer dental cement

Fisher & Paykel Healthcare - 09420012470942

Optiflow Nasal Filtered Interface with CO2 Sampling Medium
FISHER & PAYKEL HEALTHCARE LIMITED
AA031JM
In Commercial Distribution

  • 09420012470959 ()
  • 09420012470942 ()

  • MEDIUM
AA031JM

  • Nasal oxygen cannula, basic

Fisher & Paykel Healthcare - 09420012461117

Adult Optiflow Heated Circuit Kit
FISHER & PAYKEL HEALTHCARE LIMITED
950A40J
In Commercial Distribution

  • 09420012461223 ()
  • 09420012461117 ()
950A40J

  • Ventilator breathing circuit, single-use

Fluoro Care Anti-Fade Mountant - 00847627002471

No Description
BIOCARE MEDICAL LLC
FP001G5
In Commercial Distribution

  • 00847627002471 ()


  • Microscopy mounting medium IVD

Fluoro Care Anti-Fade Mountant - 00847627002464

No Description
BIOCARE MEDICAL LLC
FP001G10
In Commercial Distribution

  • 00847627002464 ()


  • Microscopy mounting medium IVD

20q13.2 Aqua - 00847627000675

No Description
BIOCARE MEDICAL LLC
PFA7325V
In Commercial Distribution

  • 00847627000675 ()


  • Nucleic acid hybridization detection IVD, probe

MYC (8q24) Green - 00847627000668

No Description
BIOCARE MEDICAL LLC
PFA7322V
In Commercial Distribution

  • 00847627000668 ()


  • Nucleic acid hybridization detection IVD, probe

TERC (3q26.2) Red - 00847627000651

No Description
BIOCARE MEDICAL LLC
PFA7305V
In Commercial Distribution

  • 00847627000651 ()


  • Nucleic acid hybridization detection IVD, probe

ERBB2 (17q12) Red - 00847627000637

No Description
BIOCARE MEDICAL LLC
PFA7274V
In Commercial Distribution

  • 00847627000637 ()


  • Nucleic acid hybridization detection IVD, probe

CDKN2A (9p21.3) Orange - 00847627000620

No Description
BIOCARE MEDICAL LLC
PFA7264V
In Commercial Distribution

  • 00847627000620 ()


  • Nucleic acid hybridization detection IVD, probe

ATM (11q22.3) Aqua - 00847627000613

No Description
BIOCARE MEDICAL LLC
PFA7263V
In Commercial Distribution

  • 00847627000613 ()


  • Nucleic acid hybridization detection IVD, probe

20q13.2 Orange - 00847627000606

No Description
BIOCARE MEDICAL LLC
PFA7255V
In Commercial Distribution

  • 00847627000606 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000590

No Description
BIOCARE MEDICAL LLC
PFA7251V
In Commercial Distribution

  • 00847627000590 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Green - 00847627000583

No Description
BIOCARE MEDICAL LLC
PFA7250V
In Commercial Distribution

  • 00847627000583 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 17 Green - 00847627000576

No Description
BIOCARE MEDICAL LLC
PFA7225V
In Commercial Distribution

  • 00847627000576 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 15 Orange - 00847627000569

No Description
BIOCARE MEDICAL LLC
PFA7218V
In Commercial Distribution

  • 00847627000569 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 12 Aqua - 00847627000552

No Description
BIOCARE MEDICAL LLC
PFA7211V
In Commercial Distribution

  • 00847627000552 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000545

No Description
BIOCARE MEDICAL LLC
PFA7200V
In Commercial Distribution

  • 00847627000545 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Aqua - 00847627000538

No Description
BIOCARE MEDICAL LLC
PFA7185V
In Commercial Distribution

  • 00847627000538 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Green - 00847627000521

No Description
BIOCARE MEDICAL LLC
PFA7184V
In Commercial Distribution

  • 00847627000521 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 6q11.1 Aqua - 00847627000514

No Description
BIOCARE MEDICAL LLC
PFA7179V
In Commercial Distribution

  • 00847627000514 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 6q11.1 Green - 00847627000507

No Description
BIOCARE MEDICAL LLC
PFA7178V
In Commercial Distribution

  • 00847627000507 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000491

No Description
BIOCARE MEDICAL LLC
PFA7164V
In Commercial Distribution

  • 00847627000491 ()


  • Nucleic acid hybridization detection IVD, probe

ATM (11q22.3) Green - 00847627000484

No Description
BIOCARE MEDICAL LLC
HFA7316A
In Commercial Distribution

  • 00847627000484 ()


  • Nucleic acid hybridization detection IVD, probe

RB1 (13q14.2) Green - 00847627000477

No Description
BIOCARE MEDICAL LLC
HFA7315A
In Commercial Distribution

  • 00847627000477 ()


  • Nucleic acid hybridization detection IVD, probe

6q21 Green - 00847627000460

No Description
BIOCARE MEDICAL LLC
HFA7309A
In Commercial Distribution

  • 00847627000460 ()


  • Nucleic acid hybridization detection IVD, probe

1q21.3 Orange - 00847627000453

No Description
BIOCARE MEDICAL LLC
HFA7308A
In Commercial Distribution

  • 00847627000453 ()


  • Nucleic acid hybridization detection IVD, probe

1p21.2 Green - 00847627000446

No Description
BIOCARE MEDICAL LLC
HFA7307A
In Commercial Distribution

  • 00847627000446 ()


  • Nucleic acid hybridization detection IVD, probe

TP53 (17p13) Orange - 00847627000439

No Description
BIOCARE MEDICAL LLC
HFA7306A
In Commercial Distribution

  • 00847627000439 ()


  • Nucleic acid hybridization detection IVD, probe

RB1 (13q14.2) Orange - 00847627000422

No Description
BIOCARE MEDICAL LLC
HFA7298A
In Commercial Distribution

  • 00847627000422 ()


  • Nucleic acid hybridization detection IVD, probe

MYB (6q23) Orange - 00847627000415

No Description
BIOCARE MEDICAL LLC
HFA7283A
In Commercial Distribution

  • 00847627000415 ()


  • Nucleic acid hybridization detection IVD, probe

LAMP1 (13q34) Aqua - 00847627000408

No Description
BIOCARE MEDICAL LLC
HFA7282A
In Commercial Distribution

  • 00847627000408 ()


  • Nucleic acid hybridization detection IVD, probe

LAMP1 (13q34) Green - 00847627000392

No Description
BIOCARE MEDICAL LLC
HFA7281A
In Commercial Distribution

  • 00847627000392 ()


  • Nucleic acid hybridization detection IVD, probe

IGH (14q32) Variable Green - 00847627000385

No Description
BIOCARE MEDICAL LLC
HFA7279A
In Commercial Distribution

  • 00847627000385 ()


  • Nucleic acid hybridization detection IVD, probe

IGH (14q32) Constant Orange - 00847627000378

No Description
BIOCARE MEDICAL LLC
HFA7278A
In Commercial Distribution

  • 00847627000378 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Orange - 00847627000361

No Description
BIOCARE MEDICAL LLC
HFA7277A
In Commercial Distribution

  • 00847627000361 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Aqua - 00847627000354

No Description
BIOCARE MEDICAL LLC
HFA7276A
In Commercial Distribution

  • 00847627000354 ()


  • Nucleic acid hybridization detection IVD, probe

D13S319 (13q14.2) Orange - 00847627000347

No Description
BIOCARE MEDICAL LLC
HFA7267A
In Commercial Distribution

  • 00847627000347 ()


  • Nucleic acid hybridization detection IVD, probe
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