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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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U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374B
In Commercial Distribution

  • 10889942361793 ()
DYNJ902374B

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374I
In Commercial Distribution

  • 40193489977920 ()
  • 10193489977929 ()
DYNJ902374I

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374C
In Commercial Distribution

  • 10889942530533 ()
DYNJ902374C

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374G
In Commercial Distribution

  • 40193489931939 ()
  • 10193489931938 ()
DYNJ902374G

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ901408D
In Commercial Distribution

  • 10889942236633 ()
DYNJ901408D

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374A
In Commercial Distribution

  • 10889942195466 ()
DYNJ902374A

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374D
In Commercial Distribution

  • 10889942759378 ()
DYNJ902374D

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374K
In Commercial Distribution

  • 10195327505844 ()
DYNJ902374K

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421B
In Commercial Distribution

  • 10195327410698 ()
DYNJ908421B

  • General surgical procedure kit, non-medicated, single-use
U Drape
O&M HALYARD, INC.
48067
In Commercial Distribution

  • 30680651480676 ()
  • 10680651480672 ()
48067

  • Patient surgical drape, single-use
U Drape
O&M HALYARD, INC.
48057
In Commercial Distribution

  • 30680651480577 ()
  • 10680651480573 ()
48057

  • Patient surgical drape, single-use
U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421C
In Commercial Distribution

  • 10198459320484 ()
DYNJ908421C

  • General surgical procedure kit, non-medicated, single-use
U Pin
Rti Surgical, Inc.
999001
In Commercial Distribution

  • 00191083044460 ()
999001

  • General internal orthopaedic fixation system implantation kit
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374L
In Commercial Distribution

  • 10198459128899 ()
DYNJ902374L

  • General surgical procedure kit, non-medicated, single-use
U Drape
O&M HALYARD, INC.
48069
In Commercial Distribution

  • 90680651480692 ()
  • 30680651480690 ()
48069

  • Patient surgical drape, single-use, non-sterile
U Drape
O&M HALYARD, INC.
48098
In Commercial Distribution

  • 30680651480980 ()
  • 20680651480983 ()
  • 90680651480982 ()
48098

  • Patient surgical drape, single-use, non-sterile
TRIAL (U)
KURARAY NORITAKE DENTAL INC.
#4232-KA
In Commercial Distribution

  • EKUR004232KA1 ()


  • Dental composite resin
PLT (U)
KURARAY NORITAKE DENTAL INC.
#3191-KA
In Commercial Distribution

  • EKUR003191KA0 ()
  • EKUR003191KA1 ()


  • Dental composite resin
Syringe (U)
KURARAY NORITAKE DENTAL INC.
#3181-KA
In Commercial Distribution

  • EKUR003181KA1 ()


  • Dental composite resin
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
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