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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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No Description
Hunter Amenities (Shantou) Co., Ltd.
50916000031
In Commercial Distribution

  • 06974675410744 ()


  • Basic manual toothbrush
Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New Zealand AC Power Cord Cable, Australia/New Zealand - PN 415-0010
Caire Diagnostics Inc.
Fenom Pro, Australia/New Zealand
In Commercial Distribution

  • 00860008017949 ()
900-0012

  • Diagnostic spirometer, professional
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
4c
In Commercial Distribution

  • 00852305002070 ()


  • Denture reliner, soft, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution

  • 00852305002018 ()


  • Denture reliner, soft, home-use
Noise Reduction Transformer, 100V
ST. JUDE MEDICAL, INC.
H702490
In Commercial Distribution

  • 05415067024909 ()
H702490

  • Constant-voltage transformer
Noise Reduction Transformer, 120V
ST. JUDE MEDICAL, INC.
H702484
In Commercial Distribution

  • 05415067024848 ()
H702484

  • Constant-voltage transformer
Noise Reduction Transformer, 240V
ST. JUDE MEDICAL, INC.
H702483
In Commercial Distribution

  • 05415067024831 ()
H702483

  • Constant-voltage transformer
DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041000
In Commercial Distribution

  • 08056446900666 ()


  • Constant-voltage transformer
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041001
In Commercial Distribution

  • 08056446900659 ()


  • Constant-voltage transformer
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
MAJESTIC DRUG CO. INC.
1
In Commercial Distribution

  • 00010705400968 ()
  • 50010705400963 ()
  • 30010705400969 ()
  • 40010705400966 ()
  • 20010705400962 ()


  • Denture reliner, soft, home-use
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755199686 ()
X-095.12.252

  • Constant-voltage transformer
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755199679 ()
X-095.12.250

  • Constant-voltage transformer
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494101960 ()


  • Denture reliner, soft, home-use
Isolation Transformer
PENTAX OF AMERICA, INC.
9175
In Commercial Distribution

  • 04961333230334 ()


  • Constant-voltage transformer
ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS
PENTAX OF AMERICA, INC.
90075
In Commercial Distribution

  • 04961333241392 ()


  • Constant-voltage transformer
JUSTI DENTURE RELINER SEMI RGD 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0010
In Commercial Distribution

  • D772ATI1400100 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER V/SOFT 1-OZ LIQUID&POWDERS
AMERICAN TOOTH INDUSTRIES
072-14-0009
In Commercial Distribution

  • D772ATI1400090 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER SOFT 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0008
In Commercial Distribution

  • D772ATI1400080 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER POWDEER 1LB
AMERICAN TOOTH INDUSTRIES
072-14-0007
In Commercial Distribution

  • D772ATI1400070 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8OZ V/SFT LIQUID
AMERICAN TOOTH INDUSTRIES
072-14-0006
In Commercial Distribution

  • D772ATI1400060 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8OZ SOFT LIQUID
AMERICAN TOOTH INDUSTRIES
072-14-0005
In Commercial Distribution

  • D772ATI1400050 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8 OZ LIQUID S/RGD
AMERICAN TOOTH INDUSTRIES
072-0004
In Commercial Distribution

  • D772ATI1400040 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT VERY SOFT
AMERICAN TOOTH INDUSTRIES
072-14-0003
In Commercial Distribution

  • D772ATI1400030 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT SOFT
AMERICAN TOOTH INDUSTRIES
072-14-0002
In Commercial Distribution

  • D772ATI1400020 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT SEMI-RGD
AMERICAN TOOTH INDUSTRIES
072-14-0001
In Commercial Distribution

  • D772ATI1400010 ()


  • Denture reliner, soft, home-use
Air Force 1000 P.U. US NSM
NEW SOURCE MEDICAL, LLC
S2002-3141
In Commercial Distribution

  • 00851830007321 ()


  • Alternating-pressure bed mattress overlay system
NSM 1400 with male coupling Cover QLT- 1p
NEW SOURCE MEDICAL, LLC
S2816-A040
In Commercial Distribution

  • 10851830007311 ()
  • 00851830007314 ()


  • Alternating-pressure bed mattress overlay system
NSM 3000 with male coupling Cover QLT - 1p
NEW SOURCE MEDICAL, LLC
S2816-A030
In Commercial Distribution

  • 10851830007304 ()
  • 00851830007307 ()


  • Alternating-pressure bed mattress overlay system
NSM LB Cover QLT -1p
NEW SOURCE MEDICAL, LLC
S2816-A020
In Commercial Distribution

  • 10851830007298 ()
  • 00851830007291 ()


  • Alternating-pressure bed mattress overlay system
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