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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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Anterior Cervical Discectomy Fusion Cage (Flat) L11 x W12 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207236 ()
ACF.11120005

  • Bone-screw internal spinal fixation system, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L15 x W18 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802598 ()

  • Height: 5 Millimeter
TAC.15180705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L15 x W18 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802512 ()

  • Height: 5 Millimeter
TAC.15180005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L14 x W16 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802413 ()

  • Height: 5 Millimeter
TAC.14160005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L12 x W14 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802314 ()

  • Height: 5 Millimeter
TAC.12140005

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L11 x W12 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802239 ()

  • Height: 5 Millimeter
TAC.11120705

  • Metallic spinal fusion cage, non-sterile
Anterior Cervical Discectomy Fusion Titanium Cage L11 x W12 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039802154 ()

  • Height: 5 Millimeter
TAC.11120005

  • Metallic spinal fusion cage, non-sterile
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle
WAG Premium Arm GEN5 No Qualcomm/Homedics BT App
WALGREEN CO.
897652
In Commercial Distribution

  • 00311917206974 ()
  • 10311917206971 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
SPRAY SET ENDOSCOPIC APP. 5MMX40 CM, 11:1 RATIO
Micromedics, Inc.
SA-3658
In Commercial Distribution

  • 00815634020191 ()
  • 10815634020198 ()
  • 20815634020195 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
SPRAY SET ENDOSCOPIC APP. 5MMX30 CM, 11:1 RATIO
Micromedics, Inc.
SA-3657
In Commercial Distribution

  • 00815634020177 ()
  • 10815634020174 ()
  • 20815634020171 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
DBD-PUMP, APP W/PAD, AERO PULSE, 31" X 6
MEDLINE INDUSTRIES, INC.
MSC80700A
In Commercial Distribution

  • 30080196669886 ()
MSC80700A

  • Alternating-pressure inflator
Tampons, Retail, App. Reg.25/Super 10/Super+ 10
Cora
02Tampons-322
In Commercial Distribution

  • 00850373007041 ()
  • 00810042481893 ()


  • Menstrual tampon, unscented
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR144PU
In Commercial Distribution

  • 06946725526668 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW144PU
In Commercial Distribution

  • 06946725526651 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP144PU
In Commercial Distribution

  • 06946725526644 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA144PU
In Commercial Distribution

  • 06946725526637 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP144PV
In Commercial Distribution

  • 06946725526620 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA144PV
In Commercial Distribution

  • 06946725526613 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR116PU
In Commercial Distribution

  • 06946725526606 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW116PU
In Commercial Distribution

  • 06946725526590 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP116PU
In Commercial Distribution

  • 06946725526583 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA116PU
In Commercial Distribution

  • 06946725526576 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP116PV
In Commercial Distribution

  • 06946725526569 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA116PV
In Commercial Distribution

  • 06946725526552 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR203PU
In Commercial Distribution

  • 06946725526545 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR136PU
In Commercial Distribution

  • 06946725526538 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR103PU
In Commercial Distribution

  • 06946725526521 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW203PU
In Commercial Distribution

  • 06946725526514 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW136PU
In Commercial Distribution

  • 06946725526507 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW103PU
In Commercial Distribution

  • 06946725526491 ()


  • Pulse Co-oximeter probe, reusable
Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP203PU
In Commercial Distribution

  • 06946725526484 ()


  • Pulse Co-oximeter probe, reusable
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