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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OB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300D
Not in Commercial Distribution

  • 05690977308640 ()
515300D

  • Cervical spine immobilization head ring
CB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500C
Not in Commercial Distribution

  • 05690977308633 ()
515500C

  • Cervical spine immobilization head ring
CB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400C
Not in Commercial Distribution

  • 05690977308626 ()
515400C

  • Cervical spine immobilization head ring
CB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300C
Not in Commercial Distribution

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring
SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
SW APP A820 TDD PATIENT PROG
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00643169771048 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00643169771031 ()


  • Infusion pump programmer
SFW 9735913 STEALTH S8 STEALTHVIZ APP
MEDTRONIC NAVIGATION, INC.
9735913
In Commercial Distribution

  • 00643169940765 ()


  • Neurological stereotactic surgery system
Bone Graft App Plugger & Scoop, Z-Line
Karl Schumacher Dental, LLC
SPA1422
In Commercial Distribution

  • 00842517117266 ()


  • Periosteal elevator, reusable
SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system
SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system
SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system
KIT TISSEEL APP 16GA X 3.75
MEDLINE INDUSTRIES, INC.
DYNDA2944
In Commercial Distribution

  • 40195327155569 ()
  • 10195327155568 ()
DYNDA2944

  • General surgical procedure kit, non-medicated, single-use
APP,RS SMART 3D,1.0,ANDR
Gn Hearing A/S
20410700
In Commercial Distribution

  • 05708296071524 ()


  • Hearing aid/implant system remote control
APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control
STRL ALLENTWN LAP CHOLE APP PK
Cardinal Health 200, LLC
SLC11LLSLG
In Commercial Distribution

  • 50885425518300 ()
  • 10885425518302 ()
SLC11LLSLG

  • Laparoscopic surgical procedure kit, non-medicated, single-use
DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay system
DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system
APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
SCS Remote App (compatible with Android)
NALU MEDICAL, INC.
53002-001
In Commercial Distribution

  • 00812537030470 ()
53002-001

  • Implantable electrical stimulation device management software
LAMP Words For Life (US) App
PRENTKE ROMICH COMPANY
LAMP WFL App
In Commercial Distribution

  • 00816486021084 ()
16659

  • Voice synthesizer/digitizer
LAMP Words For Life (UK) App
PRENTKE ROMICH COMPANY
LAMP WFL (UK) App
In Commercial Distribution

  • 00816486021077 ()
16659-2

  • Voice synthesizer/digitizer
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