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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CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution

  • D00261N0021 ()

  • 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002

  • Dental appliance fabrication material, ceramic
CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks
DENTSPLY INTERNATIONAL INC.
607103
Not in Commercial Distribution

  • D0026071031 ()

  • 4 blocks, 3 Firing Pads, 1 Syringe Coupling Agent, 1 Overglaze, 1 Stain & Glaze Liquid, 1 Calibra Ceram Syringe, 10 mix tips, 1 mixing well, 1 bottle Prime&Bond elect, 25 flocked applicator tips
607103

  • Dental appliance fabrication material, ceramic
Gauze Non Woven Sponges 4 x 4 Inch
Proguard Health, Inc
PG-4404
In Commercial Distribution

  • D066PG44042 ()
  • D066PG44041 ()
  • D066PG44040 ()
PG-4404

  • Non-woven gauze pad, non-sterile
Gauze Non Woven Sponges 3 x 3 Inch
Proguard Health, Inc
PG-3304
In Commercial Distribution

  • D066PG33042 ()
  • D066PG33041 ()
  • D066PG33040 ()
PG-3304

  • Non-woven gauze pad, non-sterile
Gauze Non Woven Sponges 2 x 2 Inch
Proguard Health, Inc
PG-2204
In Commercial Distribution

  • D066PG22042 ()
  • D066PG22041 ()
  • D066PG22040 ()
PG-2204

  • Non-woven gauze pad, non-sterile
No Description
BIOTEX, INC.
033-1000
Not in Commercial Distribution

  • M710SCVS0 ()
  • M710SCVS2 ()
SC-VS

  • Rigid non-bladed intubation laryngoscope, video
Artificial Saliva - Dry Mouth Spray
Oralabs, LLC
002
In Commercial Distribution

  • 00050428446102 ()
  • D132DMS0020 ()

  • Total Volume: 1.5 Fluid Ounce


  • Artificial saliva
Artificial Saliva - Dry Mouth Spray
Oralabs, LLC
001
In Commercial Distribution

  • D132DMS0010 ()
  • 00050428277362 ()

  • Total Volume: 7.5 Milliliter


  • Artificial saliva
Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689BH01010 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
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