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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VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
Preventech
772215
Not in Commercial Distribution

  • D024772215 ()
  • D0247722155 ()
772215

  • Dental coating, tooth-desensitizing, professional
VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit dose packages
Preventech
772155
Not in Commercial Distribution

  • D024772155 ()
  • D0247721555 ()
772155

  • Dental coating, tooth-desensitizing, professional
VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
Preventech
772145
Not in Commercial Distribution

  • D024772145 ()
  • D0247721455 ()
772145

  • Dental coating, tooth-desensitizing, professional
No Description
Varian Medical Systems Deutschland GmbH
AL07348000
In Commercial Distribution

  • 10816389020518 ()
  • 00816389020511 ()
AL07348000

  • General-purpose brachytherapy system applicator, remote-afterloading
NCI Spatula (Box of 10)
Fischer Surgical, Inc.
NCI (Box of 10)
In Commercial Distribution

  • 00860010356203 ()
  • 00860010356265 ()
9288

  • Donor cornea delivery set
Amoils Epithelial Scrubber - Hyperopic Pack of 25
Innova Medical Ophthalmics Inc
Hyperopic Pack of 25
In Commercial Distribution

  • 00628693343046 ()
  • 00628693343015 ()
AM1EX-HYPx

  • Corneal bur system, battery-powered
Amoils Epithelial Scrubber - Myopic Pack of 25
Innova Medical Ophthalmics Inc
Myopic Pack of 25
In Commercial Distribution

  • 00628693343039 ()
  • 00628693343008 ()
AM1EX-MYOPICx

  • Corneal bur system, battery-powered
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
Case of 6 bottles
In Commercial Distribution

  • 00660483150069 ()
1500

  • Medical device cleaning agent
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
Bottle of 100 tabs
In Commercial Distribution

  • 00660483150014 ()
1500-1

  • Medical device cleaning agent
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
case of 8 bottles
In Commercial Distribution

  • 00660483210800 ()
2018

  • Medical device cleaning agent
UDI OUT OF USE 1 Carton - 5 Inner Boxes / Carton, 10 Pouches / Inner Box, 10 Packs / Pouch.
BIOMEDICAL LIFE SYSTEMS, INC.
OUT OF USE- EERC200M
Not in Commercial Distribution

  • 00857771003941 ()
EERC200M - UDI OUT OF USE

  • Transcutaneous electrical stimulation electrode, single-use
UDI OUT OF USE 1 Pouch - 10 Packs / Pouch.
BIOMEDICAL LIFE SYSTEMS, INC.
OUT OF USE - EERC200M
Not in Commercial Distribution

  • 00857771003897 ()
EERC200M - UDI OUT OF USE

  • Transcutaneous electrical stimulation electrode, single-use
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
case of 8 bottles
In Commercial Distribution

  • 00660483190805 ()
190805

  • Medical device cleaning agent
No Description
COMPASS HEALTH BRANDS CORP.
Butterfly, Box of 12
Not in Commercial Distribution

  • 10853904006077 ()


  • Drug-delivery iontophoresis patch
No Description
COMPASS HEALTH BRANDS CORP.
Large, Box of 12
Not in Commercial Distribution

  • 10853904006060 ()


  • Drug-delivery iontophoresis patch
No Description
COMPASS HEALTH BRANDS CORP.
Medium, Box of 12
Not in Commercial Distribution

  • 10853904006053 ()


  • Drug-delivery iontophoresis patch
No Description
COMPASS HEALTH BRANDS CORP.
Small, Box of 12
Not in Commercial Distribution

  • 10853904006046 ()


  • Drug-delivery iontophoresis patch
FRESH Bold Impression Material Bite Registration Cartridge
EXACTA DENTAL PRODUCTS INC
Cartridge of Bite Registration
In Commercial Distribution

  • 00815619020420 ()
1-7067

  • Silicone dental impression material
R144C Queen of Hearts (COMPLIMENTARY, PROMO)
PDT, INC.
R144C Queen of Hearts
In Commercial Distribution

  • 00813677024336 ()
R144C

  • Periodontal curette
Queen of Hearts
PDT, INC.
R144 Queen of Hearts
In Commercial Distribution

  • 00813677020987 ()
R144

  • Periodontal curette
CARISOPRODOL PLUS
UTAK LABORATORIES, INC.
CARIS+ OF F LAB24
In Commercial Distribution

  • B800CARISOFFLAB245 ()
  • B800CARISOFFLAB240 ()

  • Total Volume: 5 Milliliter
CARIS+ OF F LAB24

  • Multiple-type clinical chemistry analyte profile IVD, control
6-MONOACETYLMORPHINE LEVEL 3
UTAK LABORATORIES, INC.
6-MAM 3 OF NAVIS
In Commercial Distribution

  • B8006MAM3OFNAVIS5 ()
  • B8006MAM3OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 3 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control
6-MONOACETYLMORPHINE LEVEL 2
UTAK LABORATORIES, INC.
6-MAM 2 OF NAVIS
In Commercial Distribution

  • B8006MAM2OFNAVIS5 ()
  • B8006MAM2OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 2 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control
6-MONOACETYLMORPHINE LEVEL 1
UTAK LABORATORIES, INC.
6-MAM 1 OF NAVIS
In Commercial Distribution

  • B8006MAM1OFNAVIS5 ()
  • B8006MAM1OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 1 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Guilin Woodpecker Medical Instrument Co., Ltd.
6 pieces of equipment
In Commercial Distribution

  • 06944843606231 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Guilin Woodpecker Medical Instrument Co., Ltd.
6 pieces of equipment
In Commercial Distribution

  • 06944843606224 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Guilin Woodpecker Medical Instrument Co., Ltd.
5 pieces of equipment
In Commercial Distribution

  • 06944843606217 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Guilin Woodpecker Medical Instrument Co., Ltd.
5 pieces of equipment
In Commercial Distribution

  • 06944843606200 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
URO-TRAPPER DRAIN BAGS, STERILE
SCHUERCH CORPORATION
800-0098-M (ONE OF TEN)
In Commercial Distribution

  • 00810014601243 ()


  • Surgical tissue/fluid collection bag
The University of Minnesota Retractor is used to hold mucoperiosteal flaps, cheeks, lips, and tongue away from the surgical area
Suncoast Dental, Inc
Retractor U of M
In Commercial Distribution

  • 00083208130229 ()
Retractor U of M

  • Hand-held dental retractor
Catalog Number: 10401 Kit: 1 SET OF BED DECKS (BOX 1 OF 2)
Dynarex Corporation
10401-DK-1
In Commercial Distribution

  • 00616784040110 ()


  • Basic electric home bed
Chain of Custody Disposable Sensors
NOVASOM, INC.
NS2010
Not in Commercial Distribution

  • 00860512000246 ()


  • Home-use sleep apnoea recording system
PSP,BAPTIST HOSPITAL OF MIAMI
MEDLINE INDUSTRIES, INC.
6310043851
In Commercial Distribution

  • 20193489108115 ()
  • 10193489108118 ()
6310043851

  • Angiography kit
MTO,TUBE,TRAY-UNIV OF WA-PG
MEDLINE INDUSTRIES, INC.
652110644
In Commercial Distribution

  • 10193489076776 ()
  • 20193489076773 ()
652110644

  • Angiography kit
MTO,NEURO,RADIOLOGY-UNIV.,OF NC
MEDLINE INDUSTRIES, INC.
65140283
In Commercial Distribution

  • 10193489062137 ()
  • 20193489062134 ()
65140283

  • Angiography kit
MTS NEURO KIT-UNIVERSITY OF IOWA
MEDLINE INDUSTRIES, INC.
60210269
In Commercial Distribution

  • 20193489051923 ()
  • 10193489051926 ()
60210269

  • Angiography kit
MTO CONTRAST KIT-UNIV. OF PITTSBURG
MEDLINE INDUSTRIES, INC.
60190135
In Commercial Distribution

  • 20193489050421 ()
  • 10193489050424 ()
60190135

  • Angiography kit
MTS 3V KIT-UNIV OF WASHINGTON
MEDLINE INDUSTRIES, INC.
602110612
In Commercial Distribution

  • 20193489072591 ()
  • 10193489072594 ()
602110612

  • Angiography kit
MTS RADIOLOGY KIT-UNIV OF IOWA
MEDLINE INDUSTRIES, INC.
602102610
In Commercial Distribution

  • 20193489072546 ()
  • 10193489072549 ()
602102610

  • Angiography kit
LHK,BAPTIST HOSPITAL OF MIAMI
MEDLINE INDUSTRIES, INC.
6310043852
In Commercial Distribution

  • 20193489108122 ()
  • 10193489108125 ()
6310043852

  • Angiography kit
MTO,PSP UNIV OF ILLINOIS
MEDLINE INDUSTRIES, INC.
6310340891
In Commercial Distribution

  • 20193489096498 ()
  • 10193489096491 ()
6310340891

  • Angiography kit
MTO BRONCHIAL LAVAGE-UNIV OF NC
MEDLINE INDUSTRIES, INC.
60140284
In Commercial Distribution

  • 20193489047940 ()
  • 10193489047943 ()
60140284

  • Angiography kit
Tibbs Cannula Set of 3
EAKIN SURGICAL LIMITED
S044
Not in Commercial Distribution

  • 05055299101186 ()
  • 05055299100417 ()
S044

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
STRL KAISER PERMANENTE OF CO
Cardinal Health 200, LLC
SAN45SAKP3
In Commercial Distribution

  • 50887488869146 ()
  • 10887488869148 ()
SAN45SAKP3

  • Angiography kit
KAISER PERMANENTE OF CO PACK
Cardinal Health 200, LLC
SAN45SAKP4
In Commercial Distribution

  • 50887488935742 ()
  • 10887488935744 ()
SAN45SAKP4

  • Angiography kit
VENT CIRCUIT CASE OF 10
Allied Medical, LLC
L599-130
In Commercial Distribution

  • 40026072022199 ()
  • 00026072022191 ()


  • Ventilator breathing circuit, single-use
RETROGRADE KNIFE BOX OF 6
Smith & Nephew, Inc.
4449
In Commercial Distribution

  • 23596010129417 ()
  • 03596010129413 ()
4449

  • Scalpel, single-use
TRIANGLE KNIFE BOX OF 6
Smith & Nephew, Inc.
4448
In Commercial Distribution

  • 23596010129400 ()
  • 03596010129406 ()
4448

  • Scalpel, single-use
PROBE KNIFE BOX OF 6
Smith & Nephew, Inc.
4447
In Commercial Distribution

  • 23596010129394 ()
  • 03596010129390 ()
4447

  • Stereotactic surgery system probe, reusable
LHK US UNIVERSITY OF IOWA
MEDLINE INDUSTRIES, INC.
6010080371A
In Commercial Distribution

  • 20197344098702 ()
  • 10197344098705 ()
  • 30197344098709 ()
6010080371A

  • Angiography kit
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