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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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CD HORIZON® Spinal System - 00721902685842

CD ADVANTA M9 BASE
MEDTRONIC SOFAMOR DANEK, INC.
E185074
In Commercial Distribution

  • 00721902685842 ()


  • Instrument tray, reusable

PACS Scan CD - 00850677007112

PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner

GEAR VIEW QC CD - 00850677007105

GEAR VIEW QC CD
HYLAND LLC
2
In Commercial Distribution

  • 00850677007105 ()


  • Radiological PACS software

Medline Industries, Inc. - 10889942874804

C-D & C HYSTEROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ05112C
In Commercial Distribution

  • 10889942874804 ()
  • 40889942874805 ()
DYNJ05112C

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

Specials - 10889981296308

MIS CD Tip, Offset
Seaspine Orthopedics Corporation
SR-0832
In Commercial Distribution

  • 10889981296308 ()
SR-0832

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Specials - 10889981296292

MIS CD Tip, Straight
Seaspine Orthopedics Corporation
SR-0831
In Commercial Distribution

  • 10889981296292 ()
SR-0831

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981293222

CD Tip, Lordotic, Right
Seaspine Orthopedics Corporation
MD2-103022
In Commercial Distribution

  • 10889981293222 ()
MD2-103022

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981293215

CD Tip, Lordotic, Left
Seaspine Orthopedics Corporation
MD2-103021
In Commercial Distribution

  • 10889981293215 ()
MD2-103021

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981178413

CD EXTENDED TAB ARM
Seaspine Orthopedics Corporation
MM2-000430
In Commercial Distribution

  • 10889981178413 ()
MM2-000430

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981218539

CD Extended Tab Arm
Seaspine Orthopedics Corporation
MM2-100430
In Commercial Distribution

  • 10889981218539 ()
MM2-100430

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medline Industries, Inc. - 10889942312504

LAPAROSCOPIC GASTRIC BYPASS CD
MEDLINE INDUSTRIES, INC.
CDS982608D
In Commercial Distribution

  • 10889942312504 ()
CDS982608D

  • General surgical procedure kit, medicated

NA - 00643169719972

SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software

Medline Industries, Inc. - 10889942948833

LAPAROSCOPIC GASTRIC BYPASS CD
MEDLINE INDUSTRIES, INC.
CDS982608G
In Commercial Distribution

  • 10889942948833 ()
CDS982608G

  • General surgical procedure kit, medicated

HU-FRIEDY - 10889950045456

NUB62 BURNISHER/CD NORTHWESTRN
HU-FRIEDY MFG. CO., LLC
CV1813
In Commercial Distribution

  • 10889950045456 ()
CV1813

  • Manual dental burnisher, reusable

GN ReSound - 05708296227624

CD,RS PRO-COUNSEL 1.45
Gn Hearing A/S
17351600
In Commercial Distribution

  • 05708296227624 ()


  • Audiometric/hearing device software

Medline Industries, Inc. - 10195327108069

NEURO ANGIOGRAPHIC CD 050
MEDLINE INDUSTRIES, INC.
DYNJ81301
In Commercial Distribution

  • 40195327108060 ()
  • 10195327108069 ()
DYNJ81301

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

Publix - 00041415005723

FLSS 55YD MNT CD
PUBLIX SUPER MARKETS, INC.
2G1
In Commercial Distribution

  • 00041415005723 ()


  • Dental floss

Publix - 00041415004726

FLSS 55YD WX CD
PUBLIX SUPER MARKETS, INC.
2B9
In Commercial Distribution

  • 00041415004726 ()


  • Dental floss

Publix - 00041415003729

FLSS 55YD UNWX CD
PUBLIX SUPER MARKETS, INC.
3C5
In Commercial Distribution

  • 00041415003729 ()


  • Dental floss

Somnostar - 10846446065046

CD,SOMNOSTAR VER 11.1
Carefusion Corporation
28009-001
Not in Commercial Distribution

  • 10846446065046 ()
28009-001

  • Home-use sleep apnoea recording system

Somnostar - 10846446033328

CD, LabManager HL7 Hotfix
Carefusion Corporation
30862-001
Not in Commercial Distribution

  • 10846446033328 ()
30862-001

  • Home-use sleep apnoea recording system

Vmax - 10846446032734

CD,VMAX VER 28
Carefusion Corporation
23796-001
Not in Commercial Distribution

  • 10846446032734 ()
23796-001

  • Pulmonary function analysis system, adult
  • Pulmonary function analysis system, paediatric

FreeStyle Libre - 00357599000479

FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software

Natus - 00382830039475

SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph

Natus - 00382830038003

Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph

Xltek - 00382830043489

Enterprise 5.2 Installation CD
Embla Systems Ltd
1249014
In Commercial Distribution

  • 00382830043489 ()


  • Sleep disorder interpretive software

Natus - 00382830041744

SOFT/VS CD V12.1.0
NATUS NEUROLOGY INCORPORATED
482-645100
In Commercial Distribution

  • 00382830041744 ()


  • Electromyograph

ResScan - 00619498313365

ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software

ResScan - 00619498313358

RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software

ResScan - 00619498313341

RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software

ResScan - 00619498313334

RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution

  • 00619498313334 ()
31333

  • Ventilator application software

EasyCare Tx - 00619498259441

EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution

  • 00619498259441 ()
25944

  • Ventilator application software

CARDINAL HEALTH - 10888439704143

NEURO ANGIOGRAPHIC CD 050295
Cardinal Health 200, LLC
SNE23NAUC4
In Commercial Distribution

  • 50888439704141 ()
  • 10888439704143 ()
SNE23NAUC4

  • Neurosurgical procedure kit, medicated

CD TrueFit Software v5.3 - 07613389638875

CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software

MICROETCHER - 00816594021594

MICROETCHER,CD,BIEN,FA
DANVILLE MATERIALS, LLC
93825
In Commercial Distribution

  • 00816594021594 ()
93825

  • Dental abrasive air jet system

Brasseler USA - 00887919896692

A637RED CD GENEVIEVE LAFRANCE
Peter Brasseler Holdings, LLC
5028876U0
In Commercial Distribution

  • 00887919896692 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919868781

A638PURP CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5028229U0
In Commercial Distribution

  • 00887919868781 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919822158

A638BLUE CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5027119U0
In Commercial Distribution

  • 00887919822158 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919822127

A638BLACK CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5027118U0
In Commercial Distribution

  • 00887919822127 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919817345

A600PURPL CD DESGAGNE & OUELLET
Peter Brasseler Holdings, LLC
5026936U0
In Commercial Distribution

  • 00887919817345 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919802907

A638PURPL CD TESSIER & BOUCHARD
Peter Brasseler Holdings, LLC
5026532U0
In Commercial Distribution

  • 00887919802907 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919802877

A638RED CD TESSIER & BOUCHARD
Peter Brasseler Holdings, LLC
5026531U0
In Commercial Distribution

  • 00887919802877 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919799399

A100BLUE CD GAUDREAULT/MARQUIS
Peter Brasseler Holdings, LLC
5026429U0
In Commercial Distribution

  • 00887919799399 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919797531

A637PURP CD MCLELLAND DOMPIERRE
Peter Brasseler Holdings, LLC
5026416U0
In Commercial Distribution

  • 00887919797531 ()


  • Diamond dental bur, single-use

Kit Rt. Heart CD - 00886333207893

Kit Rt. Heart CD
ARGON MEDICAL DEVICES, INC.
194409
Not in Commercial Distribution

  • 20886333207897 ()
  • 00886333207893 ()
194409

  • Invasive blood pressure transducer set

CARDINAL HEALTH - 10195594475659

NEURO ANGIO CD 050295
Cardinal Health 200, LLC
SNE23NAUC6
In Commercial Distribution

  • 50195594475657 ()
  • 10195594475659 ()
SNE23NAUC6

  • Angiography kit

Welch Allyn, Inc. - 00732094320800

XSCRIBE V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094320794

Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable

N/A - 00885074515427

CD, 9732180, LIBRARY - STEALTHLINK
MEDTRONIC NAVIGATION, INC.
9732180
Not in Commercial Distribution

  • 00885074515427 ()


  • Multi-purpose stereotactic surgery system

ADVANCED LIMB RECONSTRUCTION SYSTEM - 18032568039856

ADV SWIVELLING CD CONNECTION
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568039856 ()
53595

  • External orthopaedic fixation system, reusable
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