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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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Perifit - 03770014642226

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
Not in Commercial Distribution

  • 03770014642226 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642004

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser

CARDINAL HEALTH - 10195594541880

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00643169738058

SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer

N/A - 00643169738041

SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer

Halo Systems - 05690977308701

J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs

Cell Therapy 360 Wearable Tech V1 - 00851203006265

BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006258

BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006241

BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

GN ReSound - 05708296076703

APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
Not in Commercial Distribution

  • 05708296076703 ()


  • Hearing aid/implant system remote control
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