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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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IV STAR KIT
STRADIS MEDICAL LLC
DISV102
In Commercial Distribution

  • B704DISV1025 ()
  • B704DISV1020 ()


  • Peripheral intravenous catheterization support kit
Disposable Core Biopsy Needle
INSERT MOLDING SOLUTIONS INC
MC1825
In Commercial Distribution

  • B567MC18250 ()
  • B567MC18251 ()


  • End-cut biopsy gun handpiece/needle
Biopsy Needle
INSERT MOLDING SOLUTIONS INC
MC1820
In Commercial Distribution

  • B567MC18200 ()
  • B567MC18201 ()


  • End-cut biopsy gun handpiece/needle
BioFlo AutoValve Urine Valve
INSERT MOLDING SOLUTIONS INC
AU17
In Commercial Distribution

  • B567AU170 ()
  • B567AU171 ()


  • Urethral/suprapubic catheter valve-connector
ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667PROTOZ01 ()
  • B667PROTOZ1 ()


  • Ophthalmic fundus camera
Cavity Liner, Dental.
DENALI CORPORATION
Single Syringe - White
In Commercial Distribution

  • D820SLINER0 ()
  • D820SLINER1 ()


  • Dental composite resin
Cavity Varnish, Dental.
DENALI CORPORATION
Single - Pink
In Commercial Distribution

  • D820RCG0 ()
  • D820RCG1 ()
RCG

  • Dental cavity varnish
Light Cure Pattern, Modeling and Indexing Resin.
DENALI CORPORATION
One 3 mL Syringe
Not in Commercial Distribution

  • D820HIRO0 ()
  • D820HIRO1 ()
HIRO

  • Dental prosthesis restorative material, unfilled resin
Dental Implant Screw Mask
DENALI CORPORATION
ZEN1
In Commercial Distribution

  • D820ZEN1 ()
  • D820ZEN0 ()
ZEN

  • Dental composite resin
Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

  • D820BONOW1 ()
  • D820BONOW0 ()
BONOW

  • Dental pit/fissure sealant
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