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+ 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
Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material
Aquasil Ultra digit LV & XLV Fast Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678032
Not in Commercial Distribution

  • D0026780321 ()
678032

  • Silicone dental impression material
Aquasil Ultra digit LV & XLV Regular Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678031
Not in Commercial Distribution

  • D0026780311 ()
678031

  • Silicone dental impression material
BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing of the reagents is determined by the software, depending on reagent type.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Mixing Stations (5 pack)
In Commercial Distribution

  • 09349458001261 ()
S21.1971

  • Microscope slide stainer IVD
The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.
PFIZER INC.
F000092379
In Commercial Distribution

  • 10300130923796 ()


  • Basic growth hormone autoinjector, replaceable-cartridge
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
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800761
In Commercial Distribution

  • 03661540952579 ()


  • Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002S
Not in Commercial Distribution

  • ENTTUTG2CON8050002S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001S
Not in Commercial Distribution

  • ENTTUTG2CON8050001S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422M
Not in Commercial Distribution

  • ENTTUTG2CON8033422M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421M
Not in Commercial Distribution

  • ENTTUTG2CON8033421M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
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
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
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
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3M
Not in Commercial Distribution

  • ENTTUTG2CON80500A3M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3M

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422S
Not in Commercial Distribution

  • ENTTUTG2CON8033422S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421S
Not in Commercial Distribution

  • ENTTUTG2CON8033421S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3S
Not in Commercial Distribution

  • ENTTUTG2CON80500A3S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3M
Not in Commercial Distribution

  • ENTTUTG2CON80334A3M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°;Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3S
Not in Commercial Distribution

  • ENTTUTG2CON80334A3S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT Cartridge Kit
Not in Commercial Distribution

  • 04260364750034 ()
10049

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
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
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. This is the Rely A Bond 14g Adhesive paste in Tips.
RELIANCE ORTHODONTIC PRODUCTS INC
RPT
In Commercial Distribution

  • D798RPT1 ()
  • D798RPT0 ()
  • D798RPT2 ()
RPT

  • Orthodontic bracket adhesive
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)
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HT Shaded A3
Not in Commercial Distribution

  • D040728231 ()

  • 12mm X 98mm
72823

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HT Shaded A3
Not in Commercial Distribution

  • D040728221 ()

  • 10mm X 98mm
72822

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HT Shaded A2
Not in Commercial Distribution

  • D040728211 ()

  • 25mm X 98mm
72821

  • Custom-made dental crown, ceramic
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
WHIP-MIX CORPORATION
HT Shaded A2
Not in Commercial Distribution

  • D040728201 ()

  • 20mm X 98mm
72820

  • Custom-made dental crown, ceramic
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