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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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GN ReSound - 05708296071463

APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
Not in Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071456

APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
Not in Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control

Medline Industries, Inc. - 10195327155568

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

Medline Industries, Inc. - 10080196992980

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

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

Medline - 10080196669943

PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator

N/A - 00763000024024

SW APP A520 GU PATIENT CHRONIC
MEDTRONIC, INC.
A520
In Commercial Distribution

  • 00763000024024 ()


  • Multiple active implantable device programmer

Reveal LINQ™ Mobile Manager - 00643169636651

SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software

Halo Systems - 05690977334960

CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977326200

CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977319035

CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977308718

J TONG SML/MED- No App
OSSUR AMERICAS, INC.
JT-215
Not in Commercial Distribution

  • 05690977308718 ()
JT-215

  • Traction system skull tongs

Halo Systems - 05690977308664

OB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500D
Not in Commercial Distribution

  • 05690977308664 ()
515500D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308657

OB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400D
Not in Commercial Distribution

  • 05690977308657 ()
515400D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308640

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

  • 05690977308640 ()
515300D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308633

CB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500C
Not in Commercial Distribution

  • 05690977308633 ()
515500C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308626

CB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400C
Not in Commercial Distribution

  • 05690977308626 ()
515400C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308596

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

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring

Baha - 09321502036382

Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control

FrameLink™ - 00721902966460

SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system

SonoNav™ - 00721902865565

SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system
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