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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Night Shift Chest Belt Kit - Finnish
ADVANCED BRAIN MONITORING, INC.
NS27-4102(FIN)
In Commercial Distribution

  • 00850015266102 ()


  • Behavioural therapy electrical stimulation system
Night Shift Chest Belt Kit - Dutch
ADVANCED BRAIN MONITORING, INC.
NS27-4102(DUT)
In Commercial Distribution

  • 00850015266096 ()


  • Behavioural therapy electrical stimulation system
Night Shift Chest Belt Kit - Danish
ADVANCED BRAIN MONITORING, INC.
NS27-4102(DAN)
In Commercial Distribution

  • 00850015266089 ()


  • Behavioural therapy electrical stimulation system
Night Shift Chest Belt Kit
ADVANCED BRAIN MONITORING, INC.
NS27-4102
In Commercial Distribution

  • 00850015266072 ()


  • Behavioural therapy electrical stimulation system
Apnea Guard Scoop Kit (5)
ADVANCED BRAIN MONITORING, INC.
AG25-5301.5
In Commercial Distribution

  • 00850015266065 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
No Description
ADVANCED BRAIN MONITORING, INC.
25-5301
In Commercial Distribution

  • 00850015266058 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Starter Kit 2L2M1H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1012
In Commercial Distribution

  • 00850015266041 ()


  • Silicone dental impression material
Apnea Guard Starter Kit 1L3M1H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1009
In Commercial Distribution

  • 00850015266034 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device High (V2)
ADVANCED BRAIN MONITORING, INC.
25-1003
In Commercial Distribution

  • 00850015266027 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Medium (V2)
ADVANCED BRAIN MONITORING, INC.
25-1002
In Commercial Distribution

  • 00850015266010 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Low (V2)
ADVANCED BRAIN MONITORING, INC.
25-1001
In Commercial Distribution

  • 00850015266003 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials
TEMREX CORPORATION
730-733
In Commercial Distribution

  • 00850015110641 ()


  • Dental matrix band, single-use
A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
TEMREX CORPORATION
91-96
In Commercial Distribution

  • 00850015110634 ()


  • Dental matrix band, single-use
A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration.
TEMREX CORPORATION
97, 98, 99, 100, 101
In Commercial Distribution

  • 00850015110627 ()


  • Dental matrix band retainer
A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
TEMREX CORPORATION
26. 27, 51-76
In Commercial Distribution

  • 00850015110610 ()


  • Dental matrix band, single-use
Dental X-Ray Film Holder
TEMREX CORPORATION
2400, 2410
In Commercial Distribution

  • 00850015110542 ()


  • Dental x-ray film holder, reusable
DISPOSABLE DENTAL IMPRESSION TRAY INSERT
TEMREX CORPORATION
620, 640, 680
In Commercial Distribution

  • 00850015110535 ()


  • Dental impression material kit, single-use
DENTAL X-RAY FILM HOLDER
TEMREX CORPORATION
015, 2450
In Commercial Distribution

  • 00850015110511 ()


  • Dental x-ray film holder, reusable
DENTAL IMPRESSION TRAY AND INSERT
TEMREX CORPORATION
700, 710, 720, 760, 770, 780, 790
In Commercial Distribution

  • 00850015110498 ()


  • Dental impression material kit, single-use
DENTAL POLISHING PASTE
TEMREX CORPORATION
6800
In Commercial Distribution

  • 00850015110481 ()


  • Dentifrice
For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use.
TEMREX CORPORATION
5200, 5210
In Commercial Distribution

  • 00850015110474 ()


  • Dentifrice
A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
TEMREX CORPORATION
77-90
In Commercial Distribution

  • 00850015110450 ()


  • Dental matrix band, single-use
DENTAL CAVITY LINER DENTIN SHADE
TEMREX CORPORATION
7110
In Commercial Distribution

  • 00850015110443 ()


  • Dental acrylic resin
DENTAL CAVITY LINER DENTIN SHADE
TEMREX CORPORATION
7100
In Commercial Distribution

  • 00850015110436 ()


  • Dental acrylic resin
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6300 SYRINGE
In Commercial Distribution

  • 00850015110429 ()


  • Dental etching solution
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6200 13CC BOTTLE
In Commercial Distribution

  • 00850015110412 ()


  • Dental etching solution
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6580 60GM. BULK SYRINGE
In Commercial Distribution

  • 00850015110405 ()


  • Dental etching solution
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6575 BULK KIT
In Commercial Distribution

  • 00850015110399 ()


  • Dental etching solution
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6510 SYRINGE
In Commercial Distribution

  • 00850015110382 ()


  • Dental etching solution
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
6500 KIT
In Commercial Distribution

  • 00850015110375 ()


  • Dental etching solution
SELF-CURED DENTAL FILLING MATERIAL
TEMREX CORPORATION
7560 SYRINGE
In Commercial Distribution

  • 00850015110368 ()


  • Glass ionomer dental cement
SELF-CURED DENTAL FILLING MATERIAL
TEMREX CORPORATION
7555 Jar 18gm.
In Commercial Distribution

  • 00850015110351 ()


  • Glass ionomer dental cement
LIGHT CURE DENTAL FILLING MATERIAL
TEMREX CORPORATION
7575
In Commercial Distribution

  • 00850015110344 ()


  • Dental acrylic resin
DENTAL FILLING MATERIAL
TEMREX CORPORATION
7500
In Commercial Distribution

  • 00850015110337 ()


  • Zinc phosphate dental cement
DENTAL ETCHING PREPARATORY MATERIAL
TEMREX CORPORATION
7200 KIT
In Commercial Distribution

  • 00850015110320 ()


  • Dental etching solution
DENTIN BONDING ADHESIVE
TEMREX CORPORATION
4047
In Commercial Distribution

  • 00850015110313 ()


  • Ceramic dental inlay adhesive solution
DENTAL VARNISH AND TUBULI SEAL
TEMREX CORPORATION
4003
In Commercial Distribution

  • 00850015110306 ()


  • Dental restorative material varnish
DENTAL VARNISH AND TUBULI SEAL
TEMREX CORPORATION
4002
In Commercial Distribution

  • 00850015110290 ()


  • Dental restorative material varnish
DENTAL VARNISH AND TUBULI SEAL
TEMREX CORPORATION
4001
In Commercial Distribution

  • 00850015110283 ()


  • Dental restorative material varnish
DENTAL CEMENT
TEMREX CORPORATION
550
In Commercial Distribution

  • 00850015110276 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
451 Lt. Yellow 1lb.
In Commercial Distribution

  • 00850015110269 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
450 White 1lb.
In Commercial Distribution

  • 00850015110252 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
441 Lt. Yellow 100gm.
In Commercial Distribution

  • 00850015110245 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
440 White 100gm.
In Commercial Distribution

  • 00850015110238 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
431 Lt. Yellow 25gm.
In Commercial Distribution

  • 00850015110221 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
430 White 25gm.
In Commercial Distribution

  • 00850015110214 ()


  • Zinc oxide eugenol dental cement
LIQUID FOR MIXING WITH DENTAL CEMENT POWDER
TEMREX CORPORATION
420 4oz.
In Commercial Distribution

  • 00850015110207 ()


  • Zinc oxide eugenol dental cement
LIQUID FOR MIXING WITH DENTAL CEMENT POWDER
TEMREX CORPORATION
410 1oz.
In Commercial Distribution

  • 00850015110191 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
352 Yellow/Gray 1lb.
In Commercial Distribution

  • 00850015110184 ()


  • Zinc oxide eugenol dental cement
POWDER FOR MIXING WITH DENTAL CEMENT LIQUID
TEMREX CORPORATION
351 Yellow 1lb.
In Commercial Distribution

  • 00850015110177 ()


  • Zinc oxide eugenol dental cement
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