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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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Stem-Kit Reagents - 15099590762889

Stem-Kit Reagents
Beckman Coulter, Inc.
IM3630US
In Commercial Distribution

  • 15099590762889 ()
IM3630US

  • Multiple CD cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Finapres - 08719327003749

BeatScope 1.1a CD + User's Guide
Finapres Medical Systems B.V.
BeatScope 1.1a
In Commercial Distribution

  • 08719327003749 ()
FP_900702

  • Patient monitoring system module, blood pressure, noninvasive

Finapres - 08719327003732

BeatScope Easy CD + User's Guide
Finapres Medical Systems B.V.
BeatScope Easy
In Commercial Distribution

  • 08719327003732 ()
FP_902701

  • Patient monitoring system module, blood pressure, noninvasive

Medline Industries, Inc. - 10884389476307

STRIP-MEDI 1/2X4 3/CD
MEDLINE INDUSTRIES, INC.
DNSC29749
In Commercial Distribution

  • 40884389476308 ()
  • 10884389476307 ()
DNSC29749

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

Pathfinder SL - 10841522118128

CD ASSY PATHFINDER SL 1.8.0
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522118128 ()
063-2467-00

  • Electrocardiographic long-term ambulatory recording analyser

Pathfinder SL - 10841522124617

CD ASSY PATHFINDER SL 1.9
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522124617 ()
063-2468-00

  • Electrocardiographic long-term ambulatory recording analyser

Welch Allyn, Inc. - 00817655023106

QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor

Nucleus - 09321502043205

Custom Sound Suite 5.1 CD
COCHLEAR LIMITED
P1257243
In Commercial Distribution

  • 09321502043205 ()
P1257243

  • Audiometric/hearing device software

Actiware - 00606959057753

Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder

NA - 00643169841796

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

  • 00643169841796 ()


  • Audiometric/hearing device software

AngelMed Guardian Programmer Application User's Manual CD - 00850012625131

PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software

Juzo SoftCompress - 00640095288091

SoftCompress Pad, Breast Cup , CD
Julius Zorn, Inc.
6837BR CD
In Commercial Distribution

  • 00640095288091 ()
28809

  • General-purpose medical foam padding, reusable

AccuScreen - 05713315009006

1077 AccuScreen Service Tool CD
Natus Medical Denmark ApS
8-49-89900
In Commercial Distribution

  • 05713315009006 ()


  • Auditory stimulator

HU-FRIEDY - 10889950100872

Modified CD, ACTA Univ-Satin Ste
HU-FRIEDY MFG. CO., LLC
WEVA
Not in Commercial Distribution

  • 10889950100872 ()
WEVA

  • Dental restoration carver, amalgam, reusable

n/a - 04961333231607

CD,5109 REV.A V 3.4.1
PENTAX OF AMERICA, INC.
7194-1000
In Commercial Distribution

  • 04961333231607 ()


  • Electroglottograph

n/a - 04961333231577

CD, GAMES 5167B VERSION 3.3.0
PENTAX OF AMERICA, INC.
7193-2200
In Commercial Distribution

  • 04961333231577 ()


  • Electroglottograph

n/a - 04961333231515

CD, 3506 VERSION 3.3, REV.D
PENTAX OF AMERICA, INC.
7188-0100
In Commercial Distribution

  • 04961333231515 ()


  • Electroglottograph

n/a - 04961333231508

CD, 5104 VERSION 3.2,REV.C
PENTAX OF AMERICA, INC.
7187-9900
In Commercial Distribution

  • 04961333231508 ()


  • Electroglottograph

n/a - 04961333231492

CD, 4337 VERSION 3.2,REV.C
PENTAX OF AMERICA, INC.
7187-9000
In Commercial Distribution

  • 04961333231492 ()


  • Electroglottograph

n/a - 04961333231485

CD, 5150 VERSION 3.4.1,REV.D
PENTAX OF AMERICA, INC.
7187-8900
In Commercial Distribution

  • 04961333231485 ()


  • Electroglottograph
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