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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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NewPort - 10889981084592

Dilator 5
Seaspine Orthopedics Corporation
91-8372
In Commercial Distribution

  • 10889981084592 ()
91-8372

  • Orthopaedic retractor

Natural Extensions - 00366975000620

Mask, Earloop, Lavender
BENCO DENTAL SUPPLY CO.
3414-744
In Commercial Distribution

  • 20366975000624 ()
  • 10366975000627 ()
  • 00366975000620 ()


  • Surgical/medical face mask, single-use

X-CUBE - 08809260470828

'1:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03C
Saeshin Precision Co., Ltd.
X-CUBE #5
In Commercial Distribution

  • 08809260470828 ()


  • Dental power tool system, line-powered

BioSign Flu Controls - 10743816001492

BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

Surgical Direct - B382SD9340101000

Gass Retinal Detachment hook, 5 5/8 inch
Surgical Direct, Inc.
SD934010100
In Commercial Distribution

  • B382SD9340101000 ()
SD934010100

  • Ocular hook/spatula/manipulator, reusable

AincA® - B005GL36550

Blade, Laryngoscope, GreenLine F/O, Macintosh, English Profile, Size 5 Large Adult (184mm)
ANESTHESIA ASSOCIATES, INC.
GL-365-5
In Commercial Distribution

  • B005GL36550 ()

  • 5
GL-365-5

  • Rigid intubation laryngoscope, reusable

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

LifeSignal - B353LP11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system

ImagineMed - B353IM12101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system

ImagineMIC - B353IM11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system
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