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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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No Description
Safecare Biotech (Hangzhou) Co., Ltd.
2 tests
In Commercial Distribution

  • 06974246461298 ()
MDP-1074

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
2 tests
In Commercial Distribution

  • 06974246461205 ()
MDP-1054

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Changsha Magill Medical Technology Co., Ltd.
FlexiView #2
In Commercial Distribution

  • 16974599110390 ()
  • 06974599110393 ()
  • 86974599110399 ()

  • #2


  • Laryngeal mask airway, single-use
No Description
FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.
Mare.2
In Commercial Distribution

  • 06974416450022 ()


  • Dental delivery system instrument unit, electric
Sunquest Transfusion Manager is blood bank information system application software
CliniSys, Inc
2.x
Not in Commercial Distribution

  • B236TRM0 ()


  • Blood bank information system application software
No Description
MPS MEDICAL, INC
2 PHARM-6
In Commercial Distribution

  • 00816513020257 ()
  • 10816513020254 ()


  • Fluid transfer set, general-purpose
No Description
Manus Medical, LLC
JPK-19181 2
In Commercial Distribution

  • 20811870033418 ()
  • 00811870033414 ()


  • Closed-wound drainage kit
Eyeglass Frame,"Turtle 2, Gunmetal, 58-16-140"
ENCORE VISION, INC.
Turtle 2
In Commercial Distribution

  • 00812056033655 ()


  • Prescription spectacles
Eyeglass Frame,"Turtle 2, Brown, 58-16-140"
ENCORE VISION, INC.
Turtle 2
In Commercial Distribution

  • 00812056033648 ()


  • Prescription spectacles
AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests)
AMPLIM, LLC
A8180W-5+2
In Commercial Distribution

  • 00810477026393 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests)
AMPLIM, LLC
A8180-5+2
In Commercial Distribution

  • 00810477026379 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Curved Osteotome 1/2"
SIGNAL MEDICAL CORPORATION
1/2"
In Commercial Distribution

  • B046BIO110950 ()
BIO-1-1095

  • Orthopaedic osteotome
Straight Osteotome 1/2"
SIGNAL MEDICAL CORPORATION
1/2"
In Commercial Distribution

  • B046BIO110930 ()
BIO-1-1093

  • Orthopaedic osteotome
No Description
LED Dental Inc
Size 2
In Commercial Distribution

  • 07540201000070 ()
6101, 6101A

  • Dental digital imaging sensor, intraoral
Procellera Pin Site Rx; 2" diameter
Vomaris Wound Care, Inc.
2" Diam
In Commercial Distribution

  • 00810198030822 ()
  • 10810198030829 ()
VPK-FD20

  • Bioelectric wound dressing
ERC2, MAGEC, Shipping Pkg EU
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 2
In Commercial Distribution

  • 00812258022860 ()
EAD-M1-003

  • Distraction implant adjustment remote control
ERC2, MAGEC, Shipping Pkg UK
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 2
In Commercial Distribution

  • 00812258022853 ()
EAD-M1-002

  • Distraction implant adjustment remote control
NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software
ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010132 ()


  • Blood bank information system application software
UNIVERSITY CARBIDE ROUND #1/2
COLTENE/WHALEDENT INC
RU1001/2
In Commercial Distribution

  • D661RU100121 ()
  • D661RU100120 ()


  • Carbide dental bur, reusable
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