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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5% SODIUM FL VARNISH CARAMEL DARBY
DARBY DENTAL SUPPLY, LLC
9510059
In Commercial Distribution

  • 10889813017897 ()
  • 00889813017876 ()
9510059

  • Dental coating, tooth-desensitizing
5% SODIUM FL CLR VARNISH BGUM DARBY
DARBY DENTAL SUPPLY, LLC
9510057
In Commercial Distribution

  • 10889813017866 ()
  • 00889813017845 ()
9510057

  • Dental coating, tooth-desensitizing
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution

  • 00647529000113 ()
  • 00647529000281 ()
7400030

  • Dental coating, tooth-desensitizing
Treatment of dentinal hypersensitivity
SEPTODONT SAS SPECIALITES SEPTODONT
01S0100
In Commercial Distribution

  • 03760140703304 ()

  • Total Volume: 5 Milliliter
01S0100

  • Dental coating, tooth-desensitizing
Pain-Free™-F Desensitizer with Fluoride
PARKELL, INC.
S386
Not in Commercial Distribution

  • M595S3860 ()
S386

  • Dental coating, tooth-desensitizing
No Description
MAXILL, INC.
62189
In Commercial Distribution

  • 00060705621894 ()
  • 90060705621897 ()


  • Dental coating, tooth-desensitizing
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
DREAM FLUORIDE VARNISH CARAMEL..40 ML BOX/50
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
DFVCM
In Commercial Distribution

  • 00817169021476 ()


  • Dental coating, tooth-desensitizing
JOY Desensitizer 7ml
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
JD
In Commercial Distribution

  • 00817169020257 ()


  • Dental coating, tooth-desensitizing
DREAM FLUORIDE VARNISH SPEARMINT .40 ML BOX/50
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
DFVSM
In Commercial Distribution

  • 00817169020189 ()


  • Dental coating, tooth-desensitizing
DREAM FLUORIDE VARNISH BUBBLE GUM .40 ML BOX/50
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
DFVBG
In Commercial Distribution

  • 00817169020172 ()


  • Dental coating, tooth-desensitizing
No Description
SCOTT'S DENTAL SUPPLY L.L.C.
245-2815
In Commercial Distribution

  • D77824528151 ()
  • D77824528150 ()

  • Total Volume: 0.4 Milliliter
245-2815

  • Dental coating, tooth-desensitizing
No Description
SCOTT'S DENTAL SUPPLY L.L.C.
199-1010
In Commercial Distribution

  • D77819910101 ()
199-1010

  • Dental coating, tooth-desensitizing
No Description
BISCO INC.
B-2901
Not in Commercial Distribution

  • D757B29010 ()

  • sixe text
B-2901

  • Dental coating, tooth-desensitizing
No Description
BISCO INC.
B-2821S
Not in Commercial Distribution

  • D757B2821S1 ()

  • sixe text
B-2821S

  • Dental coating, tooth-desensitizing
No Description
BISCO INC.
B-2905P
Not in Commercial Distribution

  • D757B2905P1 ()

  • sixe text
B-2905P

  • Dental coating, tooth-desensitizing
No Description
BISCO INC.
B-2905
Not in Commercial Distribution

  • D757B29051 ()

  • sixe text
B-2905

  • Dental coating, tooth-desensitizing
No Description
BISCO INC.
B-2901P
Not in Commercial Distribution

  • D757B2901P1 ()

  • sixe text
B-2901P

  • Dental coating, tooth-desensitizing
5% SODIUM FL VARNISH CARAMEL DARBY
DARBY DENTAL SUPPLY, LLC
9510059
Not in Commercial Distribution

  • 00889813015650 ()
  • 00889813015636 ()
9510059

  • Dental coating, tooth-desensitizing
5% SODIUM FL VARNISH CARAMEL DARBY
DARBY DENTAL SUPPLY, LLC
9510058
Not in Commercial Distribution

  • 00889813015643 ()
  • 00889813015636 ()
9510058

  • Dental coating, tooth-desensitizing
5% SODIUM FL CLR VARNISH BGUM DARBY
DARBY DENTAL SUPPLY, LLC
9510057
Not in Commercial Distribution

  • 00889813015629 ()
  • 00889813015605 ()
9510057

  • Dental coating, tooth-desensitizing
5% SODIUM FL CLR VARNISH BGM DARBY
DARBY DENTAL SUPPLY, LLC
9510056
Not in Commercial Distribution

  • 00889813015612 ()
  • 00889813015605 ()
9510056

  • Dental coating, tooth-desensitizing
No Description
DR. TUNG'S PRODUCTS, INCORPORATED
82101
In Commercial Distribution

  • 00019373821013 ()


  • Ionic manual toothbrush
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
6ct checklane
Not in Commercial Distribution

  • 10037000928406 ()
  • 00037000928409 ()
  • 90037000928402 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
18ct
Not in Commercial Distribution

  • 10037000899232 ()
  • 00037000899235 ()
  • 90037000899238 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
10ct
Not in Commercial Distribution

  • 10037000899195 ()
  • 00037000899198 ()
  • 90037000899191 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
16ct
Not in Commercial Distribution

  • 10037000861604 ()
  • 00037000861607 ()
  • 90037000861600 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
12ct
Not in Commercial Distribution

  • 10037000860195 ()
  • 00037000860198 ()
  • 90037000860191 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
6ct
Not in Commercial Distribution

  • 10037000860171 ()
  • 00037000860174 ()
  • 90037000860177 ()


  • Dental coating, tooth-desensitizing
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
2ct
Not in Commercial Distribution

  • 10037000860157 ()
  • 00037000560159 ()
  • 90037000560152 ()


  • Dental coating, tooth-desensitizing
RITE AID TRAVEL DOUCHE
RITE AID CORPORATION
02700RA1
In Commercial Distribution

  • 10025715002603 ()
  • 00011822314862 ()


  • Vaginal douche, reusable
FLENTS DOUCHE KIT
APOTHECARY PRODUCTS, LLC
65200
In Commercial Distribution

  • 10025715040742 ()
  • 00025715652009 ()


  • Vaginal douche, reusable
Nu Shield 0.4 gram Unit Dose 100 Packet
NU RADIANCE INC
0.4 gram - 100 pack
In Commercial Distribution

  • B77209740 ()
0974

  • Dental coating, tooth-desensitizing
No Description
WAL-MART STORES, INC.
707050
In Commercial Distribution

  • MHC17070501 ()
  • MHC17070500 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
WAL-MART STORES, INC.
707001
In Commercial Distribution

  • MHC17070011 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
Leg Compression Pump
VIVE HEALTH LLC
RHB1019
In Commercial Distribution

  • 10818323020462 ()
  • 00818323020465 ()


  • Portable sequential venous compression system
Leg Compression Sleeve
VIVE HEALTH LLC
RHB1097
In Commercial Distribution

  • 10818323028338 ()
  • 00818323028331 ()


  • Portable sequential venous compression system
Leg Compression Sleeves (Large)
VIVE HEALTH LLC
RHB1097L
In Commercial Distribution

  • 10818323028185 ()
  • 00818323028188 ()


  • Portable sequential venous compression system
Leg Compression Sleeves (Small)
VIVE HEALTH LLC
RHB1097S
In Commercial Distribution

  • 10818323028178 ()
  • 00818323028171 ()


  • Portable sequential venous compression system
No Description
MHC MEDICAL PRODUCTS, LLC
810001
In Commercial Distribution

  • MHC18100012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
809050
In Commercial Distribution

  • MHC18090502 ()
  • MHC18090500 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
809001
In Commercial Distribution

  • MHC18090012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
807050
In Commercial Distribution

  • MHC18070502 ()
  • MHC8070500 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
807001
In Commercial Distribution

  • MHC18070012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
Hema-Glu is a dental desensitizing agent to be placed under dental cements or other restorative materials to desensitize and aid bonding primers in penetrating etched dentin.
HEALTHDENT'L, LLC
HG10020
In Commercial Distribution

  • D799HG100200 ()

  • Total Volume: 10 Milliliter
HG10020

  • Dental coating, tooth-desensitizing
Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior to placement of an amalgam restoration or placement of a crown &/or bridge.
HEALTHDENT'L, LLC
HG10010
In Commercial Distribution

  • D799HG100100 ()

  • Total Volume: 10 Milliliter
HG10010

  • Dental coating, tooth-desensitizing
No.
Dreve Otoplastik GmbH
0565
In Commercial Distribution

  • E23905651 ()
0565

  • Moisture/lubrication otic solution
No.
Dreve Otoplastik GmbH
056
In Commercial Distribution

  • E2390561 ()
056

  • Moisture/lubrication otic solution
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