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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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ZGO C-Guide Sleeve is placed into ZGO surgical guide by the dental las as appropriate for each patient anatomy and treatment plan.
VERSAH, LLC
ZCG
In Commercial Distribution

  • 00850017652750 ()


  • Surgical instrument interim-placement holder, reusable
G-Stop Holder is a holding device in the surgical operatory for the G-Stop Gauges and G-Stop Keys.
VERSAH, LLC
VGSBLK
In Commercial Distribution

  • 00850017652521 ()


  • Surgical instrument interim-placement holder, reusable
For use as a paralleling guide with the Densah Burs
VERSAH, LLC
VPLP-XL
In Commercial Distribution

  • 00850017652149 ()


  • Dental implantation depth/angle gauge, reusable
For use as a paralleling guide with the Densah Burs
VERSAH, LLC
VPLP
In Commercial Distribution

  • 00850017652132 ()


  • Dental implantation depth/angle gauge, reusable
2-in-1 Wound Repair Kit: 2 – microMend LARGE Closures 1/2 IN x 1 3/4 IN (12 mm x 43 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 178 mm); 1 – NuStat Hemostatic Dressing 4 IN x 4 IN (102 mm x 102 mm)
Kitotech Medical Inc
M1L2K006
In Commercial Distribution

  • 00850018777421 ()
M1L2K006

  • First aid kit, medicated
Wound Closure Kit: 2 – microMend LARGE Closures 1/2 IN x 1 3/4 IN (12 mm x 43 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 178 mm); 2 – Gauze Sponges 2 IN x 2 IN (51 mm x 51 mm)
Kitotech Medical Inc
M1L2K005
In Commercial Distribution

  • 00850018777414 ()
M1L2K005

  • First aid kit, medicated
Emergency Laceration Kit: 2 – microMend Closures 1/2 IN x 1 IN (12 mm x 28 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 178 mm); 2 – Gauze Packages 2 IN x 2 IN (51 mm x 51 mm)
Kitotech Medical Inc
M1S2K003
In Commercial Distribution

  • 00850018777247 ()
M1S2K003

  • First aid kit, medicated
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860127 ()
  • 05060654860080 ()
ID-CoV2-01-FPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument.
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860103 ()
  • 05060654860110 ()
ID-CoV2-01-BPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860059 ()
  • 05060654860134 ()
ID-CoV2-01-LPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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