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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SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129438 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125898 ()
040-1755-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125867 ()
040-1752-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125843 ()
040-1750-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125829 ()
040-1748-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200; 98000
In Commercial Distribution

  • 10841522125768 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522124563 ()
040-1726-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
ZIEGLER Head Mirror, 3 1/2" (90mm)
BR Surgical, LLC
BR02-18090
In Commercial Distribution

  • 00840183503697 ()
BR02-18090

  • Ophthalmic head reflector
  • Head reflector
ZIEGLER Head Mirror, 3 1/2" (90mm), with leather headband
BR Surgical, LLC
BR02-18091
In Commercial Distribution

  • 00840183519841 ()
BR02-18091

  • Ophthalmic head reflector
  • Head reflector
SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522129773 ()
040-5173-00

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
PACKAGE, EVO AND PATHFINDER SL
SPACELABS HEALTHCARE (WASHINGTON), INC
EVO Recorder
In Commercial Distribution

  • 10841522127229 ()
040-1761-00

  • Electrocardiographic ambulatory recorder
  • Electrocardiographic long-term ambulatory recording analyser
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic
Water-Based Personal Lubricant
CC Wellness LLC
40794
In Commercial Distribution

  • 10796494001414 ()
  • 00796494001417 ()


  • Sexual lubricant
No Description
FLEXICARE MEDICAL LIMITED
032-10-860U
In Commercial Distribution

  • 05055788714682 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
  • Nasal oxygen cannula, basic
  • Seizure bite block
No Description
FLEXICARE MEDICAL LIMITED
032-10-868U
In Commercial Distribution

  • 05055788714644 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
  • Nasal oxygen cannula, basic
  • Seizure bite block
No Description
FLEXICARE MEDICAL LIMITED
032-10-850U
In Commercial Distribution

  • 05055788714729 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
  • Nasal oxygen cannula, basic
  • Seizure bite block
No Description
FLEXICARE MEDICAL LIMITED
032-10-855U
In Commercial Distribution

  • 05055788714705 ()


  • Seizure bite block
  • Nasal oxygen cannula, basic
  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
FLEXICARE MEDICAL LIMITED
032-10-865U
In Commercial Distribution

  • 05055788714668 ()


  • Seizure bite block
  • Nasal oxygen cannula, basic
  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
CHURCH & DWIGHT CO., INC.
00022600973522
In Commercial Distribution

  • 00022600973522 ()
  • 80022600973207 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
CHURCH & DWIGHT CO., INC.
00022600973201
In Commercial Distribution

  • 00022600973201 ()
  • 80022600973207 ()


  • Basic male condom, Hevea-latex
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