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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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Solana C. difficile Assay
DIAGNOSTIC HYBRIDS, INC.
M307
In Commercial Distribution

  • 30014613336150 ()
M307

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile test; 120 test kit
CEPHEID
GXCDIFFICILE-120
In Commercial Distribution

  • 07332940000059 ()
GXCDIFFICILE-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile/Epi kit; 120 test kit
CEPHEID
GXCDIFF/EPI-120
In Commercial Distribution

  • 07332940000042 ()
GXCDIFF/EPI-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile test; 10 test kit
CEPHEID
GXCDIFFICILE-10
In Commercial Distribution

  • 07332940000035 ()
GXCDIFFICILE-10

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert C. difficile/Epi test; 10 test kit
CEPHEID
GXCDIFF/EPI-10
In Commercial Distribution

  • 07332940000028 ()
GXCDIFF/EPI-10

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
AmpliVue CDiff Assay
QUIDEL CORPORATION
C. difficile Assay
Not in Commercial Distribution

  • 30014613312017 ()
M201

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Direct CDIFF Assay
QUIDEL CORPORATION
Direct C. difficile Assay
In Commercial Distribution

  • 30014613311058 ()
M105

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
RINN® XCP®/BAI #3 Horizontal B/W B/B
Dentsply International Inc.
540931
In Commercial Distribution

  • D0035409310 ()
  • D0035409311 ()
540931

  • Dental x-ray film holder, reusable
No Description
BIOTEC ITALIA SRL
1077USA
In Commercial Distribution

  • 00850033906004 ()
1077USA

  • Light-energy skin surface treatment system applicator
No Description
LUMA THERAPEUTICS, INC.
CAT0581
In Commercial Distribution

  • 00860228002107 ()


  • Light-energy skin surface treatment system applicator
MaxY Handpiece, Remanufactured
Cynosure, LLC
2520B-Y026R
In Commercial Distribution

  • 00841494107611 ()


  • Light-energy skin surface treatment system applicator
MaxG HP, Artisan
Cynosure, LLC
8520A-G046
In Commercial Distribution

  • 00841494108045 ()


  • Light-energy skin surface treatment system applicator
LuxY HP, Starlux
Cynosure, LLC
1520-Y026
In Commercial Distribution

  • 00841494108007 ()


  • Light-energy skin surface treatment system applicator
Tip, Spacer, Dye Handpiece
Cynosure, LLC
130-7017-015
In Commercial Distribution

  • 00841494107970 ()


  • Light-energy skin surface treatment system applicator
No Description
QUANTA SYSTEM SPA
OAM001958
In Commercial Distribution

  • 08059173396405 ()


  • Light-energy skin surface treatment system applicator
No Description
QUANTA SYSTEM SPA
OAM001957
In Commercial Distribution

  • 08059173396399 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 650 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002028
In Commercial Distribution

  • 08059173390236 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002027
In Commercial Distribution

  • 08059173390229 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002026
In Commercial Distribution

  • 08059173390212 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002025
In Commercial Distribution

  • 08059173390205 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002024
In Commercial Distribution

  • 08059173390199 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 400 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002023
In Commercial Distribution

  • 08059173390182 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 650 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002021
In Commercial Distribution

  • 08059173390175 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 25x13 (for Discohttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#very Pico family)
QUANTA SYSTEM SPA
OAM002020
In Commercial Distribution

  • 08059173390168 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002019
In Commercial Distribution

  • 08059173390151 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002018
In Commercial Distribution

  • 08059173390144 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002017
In Commercial Distribution

  • 08059173390137 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002016
In Commercial Distribution

  • 08059173390120 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002015
In Commercial Distribution

  • 08059173390113 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002014
In Commercial Distribution

  • 08059173390106 ()


  • Light-energy skin surface treatment system applicator
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