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

  • 00721902685842 ()


  • Instrument tray, reusable
PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
GEAR VIEW QC CD
HYLAND LLC
2
In Commercial Distribution

  • 00850677007105 ()


  • Radiological PACS software
C-D & C HYSTEROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ05112C
In Commercial Distribution

  • 10889942874804 ()
  • 40889942874805 ()
DYNJ05112C

  • General surgical procedure kit, non-medicated, single-use
MIS CD Tip, Offset
Seaspine Orthopedics Corporation
SR-0832
In Commercial Distribution

  • 10889981296308 ()
SR-0832

  • Orthopaedic prosthesis implantation positioning instrument, reusable
MIS CD Tip, Straight
Seaspine Orthopedics Corporation
SR-0831
In Commercial Distribution

  • 10889981296292 ()
SR-0831

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CD Tip, Lordotic, Right
Seaspine Orthopedics Corporation
MD2-103022
In Commercial Distribution

  • 10889981293222 ()
MD2-103022

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CD Tip, Lordotic, Left
Seaspine Orthopedics Corporation
MD2-103021
In Commercial Distribution

  • 10889981293215 ()
MD2-103021

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CD EXTENDED TAB ARM
Seaspine Orthopedics Corporation
MM2-000430
In Commercial Distribution

  • 10889981178413 ()
MM2-000430

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CD Extended Tab Arm
Seaspine Orthopedics Corporation
MM2-100430
In Commercial Distribution

  • 10889981218539 ()
MM2-100430

  • Orthopaedic prosthesis implantation positioning instrument, reusable
LAPAROSCOPIC GASTRIC BYPASS CD
MEDLINE INDUSTRIES, INC.
CDS982608D
In Commercial Distribution

  • 10889942312504 ()
CDS982608D

  • General surgical procedure kit, medicated
SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software
LAPAROSCOPIC GASTRIC BYPASS CD
MEDLINE INDUSTRIES, INC.
CDS982608G
In Commercial Distribution

  • 10889942948833 ()
CDS982608G

  • General surgical procedure kit, medicated
NUB62 BURNISHER/CD NORTHWESTRN
HU-FRIEDY MFG. CO., LLC
CV1813
In Commercial Distribution

  • 10889950045456 ()
CV1813

  • Manual dental burnisher, reusable
CD,RS PRO-COUNSEL 1.45
Gn Hearing A/S
17351600
In Commercial Distribution

  • 05708296227624 ()


  • Audiometric/hearing device software
NEURO ANGIOGRAPHIC CD 050
MEDLINE INDUSTRIES, INC.
DYNJ81301
In Commercial Distribution

  • 40195327108060 ()
  • 10195327108069 ()
DYNJ81301

  • General surgical procedure kit, non-medicated, single-use
FLSS 55YD MNT CD
PUBLIX SUPER MARKETS, INC.
2G1
In Commercial Distribution

  • 00041415005723 ()


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

  • 00041415004726 ()


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

  • 00041415003729 ()


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

  • 10846446065046 ()
28009-001

  • Home-use sleep apnoea recording system
CD, LabManager HL7 Hotfix
Carefusion Corporation
30862-001
Not in Commercial Distribution

  • 10846446033328 ()
30862-001

  • Home-use sleep apnoea recording system
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
FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software
SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


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

  • 00382830038003 ()


  • Electromyograph
Enterprise 5.2 Installation CD
Embla Systems Ltd
1249014
In Commercial Distribution

  • 00382830043489 ()


  • Sleep disorder interpretive software
SOFT/VS CD V12.1.0
NATUS NEUROLOGY INCORPORATED
482-645100
In Commercial Distribution

  • 00382830041744 ()


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

  • 00619498313365 ()
31336

  • Ventilator application software
RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software
RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software
RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution

  • 00619498313334 ()
31333

  • Ventilator application software
EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution

  • 00619498259441 ()
25944

  • Ventilator application software
NEURO ANGIOGRAPHIC CD 050295
Cardinal Health 200, LLC
SNE23NAUC4
In Commercial Distribution

  • 50888439704141 ()
  • 10888439704143 ()
SNE23NAUC4

  • Neurosurgical procedure kit, medicated
CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software
MICROETCHER,CD,BIEN,FA
DANVILLE MATERIALS, LLC
93825
In Commercial Distribution

  • 00816594021594 ()
93825

  • Dental abrasive air jet system
A637RED CD GENEVIEVE LAFRANCE
Peter Brasseler Holdings, LLC
5028876U0
In Commercial Distribution

  • 00887919896692 ()


  • Diamond dental bur, single-use
A638PURP CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5028229U0
In Commercial Distribution

  • 00887919868781 ()


  • Diamond dental bur, single-use
A638BLUE CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5027119U0
In Commercial Distribution

  • 00887919822158 ()


  • Diamond dental bur, single-use
A638BLACK CD JOBIN & BOUDREAULT
Peter Brasseler Holdings, LLC
5027118U0
In Commercial Distribution

  • 00887919822127 ()


  • Diamond dental bur, single-use
A600PURPL CD DESGAGNE & OUELLET
Peter Brasseler Holdings, LLC
5026936U0
In Commercial Distribution

  • 00887919817345 ()


  • Diamond dental bur, single-use
A638PURPL CD TESSIER & BOUCHARD
Peter Brasseler Holdings, LLC
5026532U0
In Commercial Distribution

  • 00887919802907 ()


  • Diamond dental bur, single-use
A638RED CD TESSIER & BOUCHARD
Peter Brasseler Holdings, LLC
5026531U0
In Commercial Distribution

  • 00887919802877 ()


  • Diamond dental bur, single-use
A100BLUE CD GAUDREAULT/MARQUIS
Peter Brasseler Holdings, LLC
5026429U0
In Commercial Distribution

  • 00887919799399 ()


  • Diamond dental bur, single-use
A637PURP CD MCLELLAND DOMPIERRE
Peter Brasseler Holdings, LLC
5026416U0
In Commercial Distribution

  • 00887919797531 ()


  • Diamond dental bur, single-use
Kit Rt. Heart CD
ARGON MEDICAL DEVICES, INC.
194409
Not in Commercial Distribution

  • 20886333207897 ()
  • 00886333207893 ()
194409

  • Invasive blood pressure transducer set
NEURO ANGIO CD 050295
Cardinal Health 200, LLC
SNE23NAUC6
In Commercial Distribution

  • 50195594475657 ()
  • 10195594475659 ()
SNE23NAUC6

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

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable
Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable
CD, 9732180, LIBRARY - STEALTHLINK
MEDTRONIC NAVIGATION, INC.
9732180
Not in Commercial Distribution

  • 00885074515427 ()


  • Multi-purpose stereotactic surgery system
ADV SWIVELLING CD CONNECTION
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568039856 ()
53595

  • External orthopaedic fixation system, reusable
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