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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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BinaxNOW COVID-19 Ag Positive Control Swab Pack - 10811877011306

Control swabs intended for use only with BinaxNOW COVID-19 Ag product manufactured by Abbott Diagnostics Scarborough, Inc.
Alere Scarborough, Inc.
195-080
In Commercial Distribution

  • 10811877011306 ()


  • SARS-CoV-2 antigen IVD, control

ID NOW™ COVID-19 Control Swab Kit - 10811877011276

Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs
Alere Scarborough, Inc.
190-080
Not in Commercial Distribution

  • 10811877011276 ()


  • SARS-CoV-2 nucleic acid IVD, control

Alinity m - 00884999049208

Alinity m SARS-CoV-2 CTRL Kit
ABBOTT MOLECULAR INC.
09N78-085
In Commercial Distribution

  • 00884999049208 ()
09N78-085

  • SARS-CoV-2 nucleic acid IVD, control

RealTime - 00884999049086

Abbott RealTime SARS-CoV-2 Control Kit
ABBOTT MOLECULAR INC.
09N77-085
In Commercial Distribution

  • 00884999049086 ()
09N77-085

  • SARS-CoV-2 nucleic acid IVD, control

Denture, restoration, splint - 06972677874106

No Description
Modern Dental Laboratory (DG) Co., Ltd.
410
In Commercial Distribution

  • 06972677874113 ()
  • 06972677874106 ()


  • Gold dental inlay
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer

Denture - 08936214220038

Full dentures are manufactured as finished products from denture resins.
ACESO DENTAL LABORATORY COMPANY LIMITED
003
In Commercial Distribution

  • 08936214220038 ()


  • Complete upper denture
  • Complete lower denture

Denture, Restoration - 08936214221103

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
110
In Commercial Distribution

  • 08936214221110 ()
  • 08936214221103 ()


  • Complete upper denture
  • Complete lower denture

Denture, Restoration - 08936214221080

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
108
In Commercial Distribution

  • 06972677871099 ()
  • 08936214221080 ()


  • Complete upper denture
  • Complete lower denture

CARDINAL HEALTH - 10197106832615

SPINE PACK
Cardinal Health 200, LLC
SNE48LMCO4
In Commercial Distribution

  • 50197106832613 ()
  • 10197106832615 ()
SNE48LMCO4

  • Ice bag

SLM Full Denture Titanium Alloy - 06975031821273

No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031821273 ()


  • Complete upper denture
  • Complete lower denture
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