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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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Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71174
In Commercial Distribution

  • D040711740 ()


  • Dental appliance fabrication material, resin
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71147
Not in Commercial Distribution

  • D040711471 ()


  • Dental appliance fabrication material, resin
The POD
SELANE PRODUCTS, INC.
62065
In Commercial Distribution

  • D854620651 ()


  • Custom-made mouthguard
Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91002
In Commercial Distribution

  • 00860001725735 ()
  • B519910020 ()
  • 00860001725728 ()

  • Area/Surface Area: 100 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91001
In Commercial Distribution

  • 00860001725711 ()
  • B519910010 ()
  • 00860001725704 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
3M™ ESPE™ Retraction Capsule Value Pack, 56942
3M Deutschland GmbH
56942
In Commercial Distribution

  • J001702011373150 ()
  • J001702011373154 ()
56942

  • Gingival retraction kit
3M™ ESPE™ Retraction Capsule Refill, 56941
3M Deutschland GmbH
56941
In Commercial Distribution

  • J001702011373070 ()
  • J001702011373074 ()
56941

  • Gingival retraction kit
3M™ ESPE™ Retraction Capsule Sample Kit, 56940
3M Deutschland GmbH
56940
In Commercial Distribution

  • J001702011372990 ()
  • J001702011372994 ()
56940

  • Gingival retraction kit
Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7022
In Commercial Distribution

  • M90107RD70221 ()
  • M90107RD70220 ()

  • Length: 75 Millimeter
07RD7022

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7021
In Commercial Distribution

  • M90107RD70211 ()
  • M90107RD70210 ()

  • Length: 75 Millimeter
07RD7021

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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