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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ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas
DMG AMERICA, LLC
61055
In Commercial Distribution

  • D033610551 ()
  • D033610550 ()

  • Weight: 28 Gram
003-61055

  • Dental restorative material varnish
ZenithDental Natural Cure Composite 1-14g base, 1-14g Catalyst with mixing pads and spatulas
DMG AMERICA, LLC
61050
In Commercial Distribution

  • D033610501 ()
  • D033610500 ()

  • Weight: 28 Gram
003-61050

  • Dental restorative material varnish
No Description
BIOTEX, INC.
033-1000
Not in Commercial Distribution

  • M710SCVS0 ()
  • M710SCVS2 ()
SC-VS

  • Rigid non-bladed intubation laryngoscope, video
Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Dentin Shade
DENTSPLY INTERNATIONAL INC.
623702
In Commercial Distribution

  • D0026237021 ()

  • Weight: 13 Gram
  • Weight: 11 Gram
  • 6 Base (13g each), 6 Catalyst (11g each), 4 Mixing Pads
623702

  • Dental composite resin
Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Ivory Shade
DENTSPLY INTERNATIONAL INC.
623701
In Commercial Distribution

  • D0026237011 ()

  • Weight: 11 Gram
  • Weight: 13 Gram
  • 6 Base (13g each), 6 Catalyst (11g each), 4 Mixing Pads
623701

  • Dental composite resin
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
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
FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge 2 ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves 1 pr Alcohol Pads 2 ea Chlorhexidine Swab 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
08
Not in Commercial Distribution

  • M68980801R080 ()
80-801-R

  • Blood transfusion set, non-exchange
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