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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Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer
TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer
Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
The ASA (Monkey Esophagus) kit is designed for the qualitative and semi-quantitative detection of antibodies associated with Pemphigus and Bullous Pemphigoid by the indirect fluorescent antibody (IFA) technique and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA6001
In Commercial Distribution

  • 00845533001946 ()
FA6001

  • Skin antibody IVD, kit, fluorescent immunoassay
Rot Reverse Lip ASA Rigid 1 1/4 x 4in
THOMPSON SURGICAL INSTRUMENTS, INC.
45907E
Not in Commercial Distribution

  • 00841536114034 ()


  • Surgical retraction system, reusable
Rot Rev Lip ASA Malleable 1 1/4 x 8in
THOMPSON SURGICAL INSTRUMENTS, INC.
45903E
Not in Commercial Distribution

  • 00841536114027 ()


  • Surgical retraction system, reusable
STRPR 1.2 APP, DEMO BL STREAMER PRO 1.2 APP CL
Oticon A/S
139340
In Commercial Distribution

  • 05707131268600 ()


  • Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 APP CL
Oticon A/S
139350
In Commercial Distribution

  • 05707131268587 ()


  • Hearing aid neck induction loop, wireless input
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