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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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Darby Dental Supply, LLC - 00889813066409

SCALER HYGIENIST H5/J1 DE #6H
DARBY DENTAL SUPPLY, LLC
5257291
In Commercial Distribution

  • 00889813066409 ()


  • Manual dental scaler, reusable

Darby Dental Supply, LLC - 00889813066348

SCALER HYGIENIST H5/33 DE #2H
DARBY DENTAL SUPPLY, LLC
5257285
In Commercial Distribution

  • 00889813066348 ()


  • Manual dental scaler, reusable

Darby Dental Supply, LLC - 00889813066393

SCALER HYGIENIST H5/J1 DE #2H
DARBY DENTAL SUPPLY, LLC
5257290
In Commercial Distribution

  • 00889813066393 ()


  • Manual dental scaler, reusable

Darby Dental Supply, LLC - 00889813066355

SCALER HYGIENIST H5/33 DE #4H
DARBY DENTAL SUPPLY, LLC
5257286
In Commercial Distribution

  • 00889813066355 ()


  • Manual dental scaler, reusable

ROI-C - 03662663023597

ROI-C LORDOTIC COATED IMPLANT 12x15,5 H5
LDR Spine Usa, Inc.
CMC1451P
In Commercial Distribution

  • 03662663023597 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter
CMC1451P

  • Metal-polymer composite spinal interbody fusion cage

ROI-C - 03662663023535

ROI-C LORDOTIC COATED IMPLANT 12x14 H5
LDR Spine Usa, Inc.
CMC1441P
In Commercial Distribution

  • 03662663023535 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter
CMC1441P

  • Metal-polymer composite spinal interbody fusion cage

ROI-C - 03662663023474

ROI-C LORDOTIC COATED IMPLANT 14x17 H5
LDR Spine Usa, Inc.
CMC1431P
In Commercial Distribution

  • 03662663023474 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 17 Millimeter
CMC1431P

  • Metal-polymer composite spinal interbody fusion cage

ROI-C - 03662663023412

ROI-C LORDOTIC COATED IMPLANT 14x15,5 H5
LDR Spine Usa, Inc.
CMC1421P
In Commercial Distribution

  • 03662663023412 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 15.5 Millimeter
CMC1421P

  • Metal-polymer composite spinal interbody fusion cage

ROI-C - 03662663023351

ROI-C LORDOTIC COATED IMPLANT 14x14 H5
LDR Spine Usa, Inc.
CMC1411P
In Commercial Distribution

  • 03662663023351 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 14 Millimeter
CMC1411P

  • Metal-polymer composite spinal interbody fusion cage

MC+ - 03662663022040

MC+ CLOSED V.B.R. 12X14 H5 MM
LDR Spine Usa, Inc.
MC741P
In Commercial Distribution

  • 03662663022040 ()

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


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021975

MC+ CLOSED V.B.R. 14x17 H5 MM
LDR Spine Usa, Inc.
MC731P
In Commercial Distribution

  • 03662663021975 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021913

MC+ CLOSED V.B.R.14x15.5 H5 MM
LDR Spine Usa, Inc.
MC721P
In Commercial Distribution

  • 03662663021913 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021845

MC+ CLOSED V.B.R.14x14 H5 MM
LDR Spine Usa, Inc.
MC711P
In Commercial Distribution

  • 03662663021845 ()

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


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021746

MC+ OPEN V.B.R.14x17 H5 MM
LDR Spine Usa, Inc.
MC631P
In Commercial Distribution

  • 03662663021746 ()

  • Depth: 14 Millimeter
  • Width: 17 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021715

MC+ OPEN V.B.R.14x15.5 H5 MM
LDR Spine Usa, Inc.
MC621P
In Commercial Distribution

  • 03662663021715 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021685

MC+ OPEN V.B.R.14X14 H5 MM
LDR Spine Usa, Inc.
MC611P
In Commercial Distribution

  • 03662663021685 ()

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


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021623

CLOSED CERVICAL CAGE 12x15.5 H5 mm
LDR Spine Usa, Inc.
MC351P
In Commercial Distribution

  • 03662663021623 ()

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


  • Polymeric spinal fusion cage, sterile

MC+ - 03662663021425

CLOSED CERVICAL CAGE 14X15.5 H5 mm
LDR Spine Usa, Inc.
MC321P
In Commercial Distribution

  • 03662663021425 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

ROI-C - 03662663043953

ROI-C LORDOTIC MONOBLOCK TRIAL 14x17 H5
LDR Spine Usa, Inc.
MC9124R
In Commercial Distribution

  • 03662663043953 ()

  • Height: 5 Millimeter
  • Width: 17 Millimeter
  • Depth: 14 Millimeter
MC9124R

  • Spinal implant trial

ROI-C - 03662663043885

ROI-C LORDOTIC MONOBLOCK TRIAL 14x15.5 H5
LDR Spine Usa, Inc.
MC9118R
In Commercial Distribution

  • 03662663043885 ()

  • Height: 5 Millimeter
  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
MC9118R

  • Spinal implant trial

ROI-C - 03662663043823

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 - 03662663043755

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 - 03662663043694

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

KONTACT - 03701045238140

UniPost abutment Ø6.5mm H5 mm indexed
BIOTECH DENTAL
KPV655
In Commercial Distribution

  • 03701045238140 ()


  • Dental implant system

KONTACT - 03701045238058

UniPost abutment Ø4.0mm H5 mm indexed
BIOTECH DENTAL
KPV405
In Commercial Distribution

  • 03701045238058 ()


  • Dental implant system

AEON-C - 08800039870528

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

  • 08800039870528 ()
CSA.0166

  • Spinal fixation plate, non-bioabsorbable

4CIS® Marlin ACIF Cage SYSTEM - 08806373583445

4CIS® Marlin Trial 16x14, H5
ALPHANOX CO.,LTD.
5901-0161
In Commercial Distribution

  • 08806373583445 ()
5901-0161

  • Transfemoral amputation tissue-reinforcement implant trial

4CIS® Marlin ACIF Cage SYSTEM - 08806373583360

4CIS® Marlin Trial 14x14, H5
ALPHANOX CO.,LTD.
5901-0153
In Commercial Distribution

  • 08806373583360 ()
5901-0153

  • Transfemoral amputation tissue-reinforcement implant trial

4CIS® Marlin ACIF Cage SYSTEM - 08806373583285

4CIS® Marlin Trial 14x12, H5
ALPHANOX CO.,LTD.
5901-0145
In Commercial Distribution

  • 08806373583285 ()
5901-0145

  • Transfemoral amputation tissue-reinforcement implant trial

4CIS® Marlin ACIF Cage SYSTEM - 08806373583209

4CIS® Marlin Trial 12x12, H5
ALPHANOX CO.,LTD.
5901-0137
In Commercial Distribution

  • 08806373583209 ()
5901-0137

  • Transfemoral amputation tissue-reinforcement implant trial

ACDF Stand Alone Cervical - 07630040726177

Mecta-C SA – Plate Quattro Lag h5
Medacta International SA
03.18.415
In Commercial Distribution

  • 07630040726177 ()


  • Metallic spinal interbody fusion cage

ACDF Stand Alone Cervical - 07630040726092

Mecta-C SA – Plate Quattro Lock h5
Medacta International SA
03.18.405
In Commercial Distribution

  • 07630040726092 ()


  • Metallic spinal interbody fusion cage

ACDF Stand Alone Cervical - 07630040726016

Mecta-C SA – Plate Trio Lag h5
Medacta International SA
03.18.315
In Commercial Distribution

  • 07630040726016 ()


  • Metallic spinal interbody fusion cage

ACDF Stand Alone Cervical - 07630040725934

Mecta-C SA – Plate Trio Lock h5
Medacta International SA
03.18.305
In Commercial Distribution

  • 07630040725934 ()


  • Metallic spinal interbody fusion cage

NA - 07290112858788

Straight abutment H5 Internal Hex RP
UNIQA DENTAL LTD
USBR-4605
In Commercial Distribution

  • 07290112858788 ()
USBR-4605

  • Dental implant suprastructure, permanent, preformed

Omnipod 5 Controller APP - 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

N/A - 00763000523329

SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer

N/A - 00763000523312

SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer

SJM™ - 05415067023810

Patient Controller App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3871
Not in Commercial Distribution

  • 05415067023810 ()
3871

  • Multiple active implantable device programmer

SJM™ - 05415067023803

Clinician Programmer App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3870
Not in Commercial Distribution

  • 05415067023803 ()
3870

  • Multiple active implantable device programmer

NA - 05415067034977

Patient Controller App
ST. JUDE MEDICAL, INC.
55500
In Commercial Distribution

  • 05415067034977 ()
55500

  • Multiple active implantable device programmer

NA - 05415067034960

Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer

NeuroSphere™ - 05415067050311

Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer

Widex - 05706069659689

BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069599985

COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069599978

COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

CardioLabs - 00851074007248

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007194

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007170

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
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