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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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Extraoral Cassette with LANEX Regular Screens - 60889971002778

Extraoral Cass w/ LANEX REG SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002778 ()
1002773

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with LANEX Medium Screens - 60889971002747

Extraoral Cass w/ LANEX MED SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Medium Screens
In Commercial Distribution

  • 60889971002747 ()
1002740

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002730

Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Tissue Goo™ Hemostatic Gel 4-Pack - 00359883005665

Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641904
In Commercial Distribution

  • 00359883005665 ()

  • Total Volume: 12 Milliliter
641904

  • Gingival retraction solution

Acu-Flow™ Medium Body Cartridge - 00359883003371

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016408
In Commercial Distribution

  • 00359883003371 ()

  • Total Volume: 50 Milliliter
1-016408

  • Silicone dental impression material

Acu-Flow™ Light Body Plus Cartridge - 00359883003357

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016406
In Commercial Distribution

  • 00359883003357 ()

  • Total Volume: 50 Milliliter
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 00359883003340

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016405
In Commercial Distribution

  • 00359883003340 ()

  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material

Acu-Flow™ Monophase 6-Pack - 00359883003333

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016404
In Commercial Distribution

  • 00359883003326 ()
  • 00359883003333 ()

  • Total Volume: 300 Milliliter
1-016404

  • Silicone dental impression material

Acu-Flow™ Rigid Tray 6-Pack - 00359883003319

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016403
In Commercial Distribution

  • 00359883003302 ()
  • 00359883003319 ()

  • Total Volume: 300 Milliliter
1-016403

  • Silicone dental impression material

Acu-Flow™ Heavy Body 6-Pack - 00359883003296

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016402
In Commercial Distribution

  • 00359883003289 ()
  • 00359883003296 ()

  • Total Volume: 300 Milliliter
1-016402

  • Silicone dental impression material
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