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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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Hybrid HV Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5915 ()
  • M694HYB5913 ()
  • M694HYB5911 ()
HYB591

  • CPAP/BPAP face mask, reusable
Hybrid NE Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694HYB5755 ()
  • M694HYB5753 ()
  • M694HYB5751 ()
HYB575

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Medium
Innomed Technologies Inc
MD
In Commercial Distribution

  • M694HYB5735 ()
  • M694HYB5733 ()
  • M694HYB5731 ()
HYB573

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5715 ()
  • M694HYB5713 ()
  • M694HYB5711 ()
HYB571

  • CPAP/BPAP face mask, single-use
INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
STRADIS MEDICAL, LLC
525-079
Not in Commercial Distribution

  • M7525250791 ()
  • M7525250793 ()
  • M7525250792 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 11 Centimeter
525-079

  • Vascular catheter introduction set, nonimplantable
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

  • M752525038R10 ()
  • M752525038R13 ()
  • M752525038R15 ()


  • Vascular catheter introduction set, nonimplantable
Health-Tec EarLoop Masks, Sensitive, White
Dental Health Products Inc
450-10001
In Commercial Distribution

  • D773450100013 ()
  • D773450100011 ()
  • D773450100010 ()
  • D773450100015 ()
450-10001

  • Surgical/medical respirator, non-antimicrobial, single-use
The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Friction Grip Finishing Point.
RELIANCE ORTHODONTIC PRODUCTS INC
*RSP
In Commercial Distribution

  • D798RSPFG0 ()
  • D798RSPFG3 ()
  • D798RSPFG2 ()
*RSP

  • Carbide dental bur, reusable
The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Small Tips
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRS
In Commercial Distribution

  • D798EMTRS1 ()
  • D798EMTRS0 ()
  • D798EMTRS2 ()
  • D798EMTRS3 ()
EMTRS

  • Dental abrasive air jet system
The Etchmaster system is intended for use for polishing, roughening, and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is a 25 pack of the Etchmaster Small Lingual tips.
RELIANCE ORTHODONTIC PRODUCTS INC
EMTLS
In Commercial Distribution

  • D798EMTLS1 ()
  • D798EMTLS0 ()
  • D798EMTLS2 ()
  • D798EMTLS3 ()
EMTLS

  • Dental abrasive air jet system
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