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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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IPD - 08435566608650

Castable Engaging Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
CA
In Commercial Distribution

  • 08435566608650 ()
IPD/DB-HR-00

  • Dental casting unit

IPD - 08435566608391

Digital analog Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566608391 ()
IPD/DB-AR-00/3D

  • Dental implant analog

IPD - 08435566608384

Analog Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566608384 ()
IPD/DB-AR-00

  • Dental implant analog

IPD - 08435566608377

Digital analog Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566608377 ()
IPD/DB-AN-00/3D

  • Dental implant analog

IPD - 08435566608360

Analog Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566608360 ()
IPD/DB-AN-00

  • Dental implant analog

Fifty50 Sport - 00892896000260

Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000086

Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000093

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent

Fifty50 - 00892896000017

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent

MGB Alert Internal Control Set IC2-480 rxn - 03661540951411

The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800362
In Commercial Distribution

  • 03661540951411 ()
800362

  • Exogenous DNA/RNA internal control IVD, kit
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