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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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Maxi Move 5 Mobile Floor Lifter - (H) SWL 600 lb / 272 kg, (E) Extra Low Height. w/Scale, w/Motion Assist
Arjohuntleigh AB
KMEHEU-M
In Commercial Distribution

  • 05059441401094 ()
KMEHEU-M

  • Mobile patient lifting system, electrically-powered
DrugSmart Cup 5, AMP/COC/OPI/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60505D
In Commercial Distribution

  • 00850019007664 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
BIOCARE MEDICAL LLC
PME430AA
In Commercial Distribution

  • 00847627012043 ()


  • Cytokeratin IVD, antibody
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
PM105AA
In Commercial Distribution

  • 00847627010995 ()


  • Cytokeratin IVD, antibody
No Description
Biomet Uk Ltd
35-000099
In Commercial Distribution

  • 05019279040254 ()
35-000099

  • Surgical depth gauge, reusable
1- OF6030 1- BF6020 1-BF516
SUNSET HEALTHCARE SOLUTIONS, INC.
OF6030SP
In Commercial Distribution

  • 00848530104122 ()


  • Anaesthesia conduction filter
  • Respirator filter/cartridge, particulates
No Description
BIOCARE MEDICAL LLC
CME430B
In Commercial Distribution

  • 00847627007773 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
CME430A
In Commercial Distribution

  • 00847627007766 ()


  • Cytokeratin IVD, antibody
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
CM105C
In Commercial Distribution

  • 00847627006165 ()


  • Cytokeratin IVD, antibody
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
CM105B
In Commercial Distribution

  • 00847627006158 ()


  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
CM105A
In Commercial Distribution

  • 00847627006141 ()


  • Cytokeratin IVD, antibody
SYSTEM 5 Multicuff Kit,Multicuff, 1 pc Cuffs
AMERICAN DIAGNOSTIC CORP
740-MCC1
In Commercial Distribution

  • 00634782597825 ()
  • 00634782096441 ()

  • 5 Cuff, 13-66cm
740-MCC1

  • Aneroid manual sphygmomanometer
No Description
OSADA ELECTRIC CO.,LTD.
SC point 5
In Commercial Distribution

  • 04582227360229 ()
16405

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
No Description
TOKYO BOEKI MEDISYS INC.
50-27-0782
In Commercial Distribution

  • 04580262046528 ()
50-27-0782

  • Wash/cleaning solution IVD, automated/semi-automated system
"UNITED" USTAR II Knee System
UNITED ORTHOPEDIC CORP.
2215-1450
In Commercial Distribution

  • 04711605580106 ()
2215-1450

  • Rotating hinged total knee prosthesis
Conformity stem, #5
UNITED ORTHOPEDIC CORP.
1110-3005
In Commercial Distribution

  • 04711605583220 ()
1110-3005

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-2
In Commercial Distribution

  • 00856571007210 ()

  • Needle Gauge: 18 Gauge
10005-2

  • Soft-tissue biopsy needle, single-use
No Description
Ion Vision, Inc
P-IOV-047
In Commercial Distribution

  • 00850054345349 ()


  • Surgical camera lens
Endoscopic Insufflator
PALLIARE LIMITED
EVA5
In Commercial Distribution

  • 05391536920296 ()


  • Gastrointestinal endoscopic insufflator
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