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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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CS/CC MsIgG1-RD1/ MsIgG1-FITC - 15099590537319

CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-FITC
Beckman Coulter, Inc.
6603796
In Commercial Distribution

  • 15099590537319 ()
6603796

  • Multiple CD cell marker IVD, control

CC MsIgM-FITC Isotypic Control - 15099590539863

COULTER CLONE MsIgM-FITC
Beckman Coulter, Inc.
6602434
In Commercial Distribution

  • 15099590539863 ()
6602434

  • Multiple CD cell marker IVD, control

CS/CC Mo2-RD1 (CD14-RD1) - 15099590539757

CYTO-STAT/COULTER CLONE Mo2-RD1
Beckman Coulter, Inc.
6604500
In Commercial Distribution

  • 15099590539757 ()
6604500

  • Multiple CD cell marker IVD, antibody

CC CD3(IgG1)-FITC - 15099590542597

COULTER CLONE CD3(IgG1)-FITC
Beckman Coulter, Inc.
6604625
In Commercial Distribution

  • 15099590542597 ()
6604625

  • Multiple CD cell marker IVD, antibody

CC CD3(IgG1)-RD1 - 15099590542580

COULTER CLONE CD3(IgG1)-RD1
Beckman Coulter, Inc.
6604627
In Commercial Distribution

  • 15099590542580 ()
6604627

  • Multiple CD cell marker IVD, antibody

CC MsIgG1 Isotypic Control - 15099590542535

COULTER CLONE MsIgG1
Beckman Coulter, Inc.
6602872
In Commercial Distribution

  • 15099590542535 ()
6602872

  • Multiple CD cell marker IVD, control

CS/CC T8-RD1 (CD8-RD1) - 15099590542368

CYTO-STAT/COULTER CLONE T8-RD1
Beckman Coulter, Inc.
6603848
In Commercial Distribution

  • 15099590542368 ()
6603848

  • Multiple CD cell marker IVD, antibody

CS/CC T11-RD1 (CD2-RD1) - 15099590542351

CYTO-STAT/COULTER CLONE T11-RD1
Beckman Coulter, Inc.
6603849
In Commercial Distribution

  • 15099590542351 ()
6603849

  • Multiple CD cell marker IVD, antibody

CS/CC T4-RD1 (CD4-RD1) - 15099590542344

CYTO-STAT/COULTER CLONE T4-RD1
Beckman Coulter, Inc.
6603850
In Commercial Distribution

  • 15099590542344 ()
6603850

  • Multiple CD cell marker IVD, antibody

CS/CC T11-RD1/B1-FITC - 15099590540869

CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC
Beckman Coulter, Inc.
6603928
In Commercial Distribution

  • 15099590540869 ()
6603928

  • Multiple CD cell marker IVD, antibody

CS/CC T11-FITC (CD2-FITC) - 15099590540692

CYTO-STAT/COULTER CLONE T11-FITC
Beckman Coulter, Inc.
6603863
In Commercial Distribution

  • 15099590540692 ()
6603863

  • Multiple CD cell marker IVD, antibody

INSERT CC 32X75/81 - M209100840

No Description
BIOPRO, INC.
10084
In Commercial Distribution

  • M209100840 ()


  • Non-constrained polyethylene acetabular liner

OvuSense - 05060508530039

M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser

STERILE ROBOT ARM INTERFACE - 03760244030436

Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system

iProvèn - 08719481720193

Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer

DRIVEMEDICAL - 00822383103747

Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system

BIOMET - 00815634020283

RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

SURGIFORM - 00850987007864

CND-17CC Nasal Dorsal Series CC Silicone Implants
SURGICAL TECHNOLOGY LABORATORIES INC
CND-17CC
In Commercial Distribution

  • 00850987007864 ()
CND-17CC

  • Nasal cartilage support implant, non-bioabsorbable

SURGIFORM - 00850987007857

CND-16CC Nasal Dorsal Series CC Silicone Implants
SURGICAL TECHNOLOGY LABORATORIES INC
CND-16CC
In Commercial Distribution

  • 00850987007857 ()
CND-16CC

  • Nasal cartilage support implant, non-bioabsorbable

SURGIFORM - 00850987007833

CND-11CC Nasal Dorsal Series CC Silicone Implants
SURGICAL TECHNOLOGY LABORATORIES INC
CND-11CC
In Commercial Distribution

  • 00850987007833 ()
CND-11CC

  • Nasal cartilage support implant, non-bioabsorbable
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