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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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Touch Prime Ultrasound Systems / N13C5Transducer - 60889971734587

N13C5 NEONATAL CURVED ARRAY
CARESTREAM HEALTH, INC.
Touch Prime Ultrasound Systems / N13C5Transducer
Not in Commercial Distribution

  • 60889971734587 ()
1734581

  • General-purpose ultrasound imaging system

Touch Prime Ultrasound Systems / 13L4W Transducer - 60889971734556

13L4W WIDE LINEAR ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
Touch Prime Ultrasound Systems / 13L4W Transducer
Not in Commercial Distribution

  • 60889971734556 ()
1734557

  • General-purpose ultrasound imaging system

Touch Prime Ultrasound Systems / 6C2S Transducer - 60889971734549

6C2S TIGHTLY CURVED ARRAY
CARESTREAM HEALTH, INC.
Touch Prime Ultrasound Systems / 6C2S Transducer
Not in Commercial Distribution

  • 60889971734549 ()
1734540

  • General-purpose ultrasound imaging system

10L2W WIDE LINEAR ARRAY TRANSDUCER - 60889971734532

10L2W WIDE LINEAR ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
10L2W WIDE LINEAR ARRAY TRANSDUCER
Not in Commercial Distribution

  • 60889971734532 ()
1734532

  • General-purpose ultrasound imaging system

14L3 LINEAR ARRAY TRANSDUCER - 60889971734525

14L3 LINEAR ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
14L3 LINEAR ARRAY TRANSDUCER
Not in Commercial Distribution

  • 60889971734525 ()
1734524

  • General-purpose ultrasound imaging system

E10C4 ENDOCAVITY ARRAY TRANSDUCER - 60889971734518

E10C4 ENDOCAVITY ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
E10C4 ENDOCAVITY ARRAY TRANSDUCER
Not in Commercial Distribution

  • 60889971734518 ()
1734516

  • General-purpose ultrasound imaging system

18L5 LINEAR ARRAY TRANSDUCER - 60889971734501

18L5 LINEAR ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
18L5 LINEAR ARRAY TRANSDUCER
Not in Commercial Distribution

  • 60889971734501 ()
1734508

  • General-purpose ultrasound imaging system

Touch Prime Ultrasound Systems / 6C2 Transducer - 60889971734495

6C2 CURVED ARRAY TRANSDUCER
CARESTREAM HEALTH, INC.
Touch Prime Ultrasound Systems / 6C2 Transducer
Not in Commercial Distribution

  • 60889971734495 ()
1734490

  • General-purpose ultrasound imaging system

Kidney KFRE Algorithm - 07613336223321

No Description
Roche Diagnostics GmbH
09891986001
In Commercial Distribution

  • 07613336223321 ()
09891986001

  • Clinical management support software IVD

Site~Rite 8 Ultrasound System - 00801741143809

Site~Rite 8 Version 2.0.1
Bard Access Systems, Inc.
Site~Rite 8 Version 2.0.1
In Commercial Distribution

  • 00801741143809 ()
Site~Rite 8 Version 2.0.1

  • General-purpose ultrasound imaging system
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