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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ROI-C LORDOTIC MONOBLOCK TRIAL 14x14 H5
LDR Spine Usa, Inc.
MC9112R
In Commercial Distribution

  • 03662663043823 ()

  • Height: 5 Millimeter
  • Width: 14 Millimeter
  • Depth: 14 Millimeter
MC9112R

  • Spinal implant trial
ROI-C LORDOTIC MONOBLOCK TRIAL 12x15.5 H5
LDR Spine Usa, Inc.
MC9106R
In Commercial Distribution

  • 03662663043755 ()

  • Height: 5 Millimeter
  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
MC9106R

  • Spinal implant trial
ROI-C LORDOTIC MONOBLOCK TRIAL 12x14 H5
LDR Spine Usa, Inc.
MC9100R
In Commercial Distribution

  • 03662663043694 ()

  • Height: 5 Millimeter
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
MC9100R

  • Spinal implant trial
UniPost abutment Ø6.5mm H5 mm indexed
BIOTECH DENTAL
KPV655
In Commercial Distribution

  • 03701045238140 ()


  • Dental implant system
UniPost abutment Ø4.0mm H5 mm indexed
BIOTECH DENTAL
KPV405
In Commercial Distribution

  • 03701045238058 ()


  • Dental implant system
Double Ended Trials L12xW16XA7 H5 & 6
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039870528 ()
CSA.0166

  • Spinal fixation plate, non-bioabsorbable
4CIS® Marlin Trial 16x14, H5
ALPHANOX CO.,LTD.
5901-0161
In Commercial Distribution

  • 08806373583445 ()
5901-0161

  • Transfemoral amputation tissue-reinforcement implant trial
4CIS® Marlin Trial 14x14, H5
ALPHANOX CO.,LTD.
5901-0153
In Commercial Distribution

  • 08806373583360 ()
5901-0153

  • Transfemoral amputation tissue-reinforcement implant trial
4CIS® Marlin Trial 14x12, H5
ALPHANOX CO.,LTD.
5901-0145
In Commercial Distribution

  • 08806373583285 ()
5901-0145

  • Transfemoral amputation tissue-reinforcement implant trial
4CIS® Marlin Trial 12x12, H5
ALPHANOX CO.,LTD.
5901-0137
In Commercial Distribution

  • 08806373583209 ()
5901-0137

  • Transfemoral amputation tissue-reinforcement implant trial
Mecta-C SA – Plate Quattro Lag h5
Medacta International SA
03.18.415
In Commercial Distribution

  • 07630040726177 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Quattro Lock h5
Medacta International SA
03.18.405
In Commercial Distribution

  • 07630040726092 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Trio Lag h5
Medacta International SA
03.18.315
In Commercial Distribution

  • 07630040726016 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Trio Lock h5
Medacta International SA
03.18.305
In Commercial Distribution

  • 07630040725934 ()


  • Metallic spinal interbody fusion cage
Straight abutment H5 Internal Hex RP
UNIQA DENTAL LTD
USBR-4605
In Commercial Distribution

  • 07290112858788 ()
USBR-4605

  • Dental implant suprastructure, permanent, preformed
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer
SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer
Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer
Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer
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