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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
FGX INTERNATIONAL INC.
10244256.FTG
In Commercial Distribution

  • 00887661610546 ()


  • Tinted non-prescription spectacles
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
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
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
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
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
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
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