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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Aquasil Ultra+ LV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678713
In Commercial Distribution

  • D0026787130 ()
  • D0026787131 ()
678713

  • Silicone dental impression material
Aquasil Ultra+ XLV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678707
In Commercial Distribution

  • D0026787070 ()
  • D0026787071 ()
678707

  • Silicone dental impression material
Aquasil Ultra+ LV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678706
In Commercial Distribution

  • D0026787060 ()
  • D0026787061 ()
678706

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Bulk Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678704
In Commercial Distribution

  • D0026787040 ()
  • D0026787041 ()
678704

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678703
In Commercial Distribution

  • D0026787030 ()
  • D0026787031 ()
678703

  • Silicone dental impression material
Aquasil Ultra+ XLV Extended Set 4-Pack Cartridge Refill (Orange)
DENTSPLY INTERNATIONAL INC.
678701
In Commercial Distribution

  • D0026787010 ()
  • D0026787011 ()
678701

  • Silicone dental impression material
Aquasil Ultra+ digit Power XLV FS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678698
In Commercial Distribution

  • D0026786980 ()
  • D0026786981 ()
678698

  • Silicone dental impression material
Aquasil Ultra+ digit Power LV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678696
In Commercial Distribution

  • D0026786960 ()
  • D0026786961 ()
678696

  • Silicone dental impression material
Aquasil Ultra+ digit Power LV FS Small Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678694
In Commercial Distribution

  • D0026786940 ()
  • D0026786941 ()
678694

  • Silicone dental impression material
Aquasil Ultra+ digit Power XLV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678693
In Commercial Distribution

  • D0026786930 ()
  • D0026786931 ()
678693

  • Silicone dental impression material
Aquasil Ultra+ DECA Heavy/XLV Extended Set Kit
DENTSPLY INTERNATIONAL INC.
678648
Not in Commercial Distribution

  • D0026786481 ()
678648

  • Silicone dental impression material
Aquasil Ultra+ Soft Putty in DECA Delivery, Regular Set
DENTSPLY INTERNATIONAL INC.
678622
Not in Commercial Distribution

  • D0026786220 ()
  • D0026786221 ()
678622

  • Silicone dental impression material
Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is Part B of the two part system
RELIANCE ORTHODONTIC PRODUCTS INC
CIQB
Not in Commercial Distribution

  • D798CIQB0 ()
CIQB

  • Dentine bonding agent/set
3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414
3M Deutschland GmbH
69414
In Commercial Distribution

  • 04054596582620 ()
69414

  • Dental material mixing nozzle
  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ Impregum™ Penta™ Super Quick HB/LB Introductory Kit Dual, 69407
3M Deutschland GmbH
69407
In Commercial Distribution

  • 04054596582514 ()
69407

  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
  • Dental material mixing nozzle
3M™ Impregum™ Penta™ Super Quick MB/LB Introductory Kit Dual, 69415
3M Deutschland GmbH
69415
In Commercial Distribution

  • 04054596582477 ()
69415

  • Dental material injection cannula, single-use
  • Dental impression material adhesive
  • Dental material mixing nozzle
  • Polyether dental impression material
  • Dental impression material mixer
  • Gingival retraction kit
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
Heat Stress First Aid Kit, Plastic Case - Contains: Cold Pack, 4" x 5" (4); Disposable Thermometer (5); Electrolyte Drink Mix (10); Electrolyte Tablets (50); Emergency Blanket, 52" x 84"; Waterproof Tape, 1/2" X 5yd (2),
Acme United Corporation
5250
In Commercial Distribution

  • 00738743052504 ()
5250

  • First aid kit, non-medicated, reusable
CROWN AND BRIDGE MIXING TIP (25/pack) Type: T-Mixer Fine, Ratio: 10:1; For more information: https://www.scottsdental.com/catalog/product/view/id/17354/s/temporary-crown-bridge-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8110
In Commercial Distribution

  • D77810481100 ()
  • D77810481101 ()
104-8110

  • Dental material mixing nozzle
Mixing tips 45 pcs. Mixing tips used for dispensing material from auto mix cartridges for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
STERNGOLD DENTAL LLC
220220
In Commercial Distribution

  • 00841549115981 ()


  • Dental material mixing nozzle
The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module.
RANDOX LABORATORIES LIMITED
RX3950
In Commercial Distribution

  • 05055273205961 ()
RX3950

  • Buffered sample diluent IVD
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.32 Milano standard version (white/grey)
In Commercial Distribution

  • 08033928530832 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.31 Milano RFID version (white/grey)
In Commercial Distribution

  • 08033928530825 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.22 standard version (white7red shell)
In Commercial Distribution

  • 08033928530597 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.21 RFID version (white/red shell)
In Commercial Distribution

  • 08033928530580 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.02 standard version
In Commercial Distribution

  • 08033928530184 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.01 RFID version
In Commercial Distribution

  • 08033928530177 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX3.WIFI.RFID
In Commercial Distribution

  • 08033928530061 ()


  • Blood donation rocker
BD MAX Check-Points CPO contains: 24 each, Master Mix, Reagent Strips, Extraction Tubes, Sample Buffer Tubes, Septum Caps. The BD MAX Check-Points CPO Assay detects the presence of carbapenemase genes in Gram-negative bacteria and includes an internal Sample Processing Control.
Check-Points Health B.V.
278102
In Commercial Distribution

  • 00180002781029 ()
278102

  • Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)
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