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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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Venue Fit R5 Final Assembly
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278703224 ()


  • General-purpose ultrasound imaging system
Venue R5 final Assembly
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278703200 ()


  • General-purpose ultrasound imaging system
Voluson Expert 22 BT24
GE Healthcare Austria GmbH & Co OG
Expert 22 BT24
In Commercial Distribution

  • 00195278699848 ()
5934552

  • General-purpose ultrasound imaging system
Voluson Expert 20 BT24
GE Healthcare Austria GmbH & Co OG
Expert 20 BT24
In Commercial Distribution

  • 00195278699824 ()
5934553

  • General-purpose ultrasound imaging system
Voluson Expert 18 BT24
GE Healthcare Austria GmbH & Co OG
Expert 18 BT24
In Commercial Distribution

  • 00195278699800 ()
5934554

  • General-purpose ultrasound imaging system
Magna R3 LOTUS 5pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 5PP
In Commercial Distribution

  • 00195278690418 ()


  • General-purpose ultrasound imaging system
VOLUSON SIGNATURE 20
GE Ultrasound Korea Ltd.
Signature 20
In Commercial Distribution

  • 00195278633804 ()
Voluson-Signature-20

  • General-purpose ultrasound imaging system
Voluson SWIFT BT23
GE Ultrasound Korea Ltd.
SWIFT
In Commercial Distribution

  • 00195278560148 ()
5919109

  • General-purpose ultrasound imaging system
Venue R4 MD physical
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4 UPG
In Commercial Distribution

  • 00195278516534 ()


  • General-purpose ultrasound imaging system
Venue Fit R4 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516497 ()


  • General-purpose ultrasound imaging system
Versana Essiential R2 VA
GE Medical Systems (China) Co.,Ltd.
Essential R2 VA
In Commercial Distribution

  • 00195278503411 ()


  • General-purpose ultrasound imaging system
Versana Essential R2 VS
GE Medical Systems (China) Co.,Ltd.
Essential R2 VS
In Commercial Distribution

  • 00195278503404 ()


  • General-purpose ultrasound imaging system
LOGIQ E10s R2 to R3 UPG
GE Ultrasound Korea Ltd.
E10s R2 to R3 UPG
In Commercial Distribution

  • 00195278487414 ()


  • General-purpose ultrasound imaging system
Voluson P8 BT22
GE Ultrasound Korea Ltd.
P8 BT22
In Commercial Distribution

  • 00195278473103 ()
VOLUSON-P8-BT22

  • General-purpose ultrasound imaging system
Voluson S6 BT22
GE Ultrasound Korea Ltd.
S6 BT22
In Commercial Distribution

  • 00195278473080 ()
VOLUSON-S6-BT22

  • General-purpose ultrasound imaging system
Voluson S10 BT22
GE Ultrasound Korea Ltd.
S10 T22
In Commercial Distribution

  • 00195278473059 ()
VOLUSON-S10-BT22

  • General-purpose ultrasound imaging system
Voluson Signature to BT22 UPG
GE Ultrasound Korea Ltd.
Signature to BT22 UPG
In Commercial Distribution

  • 00195278473028 ()
Voluson-Signature-to-BT22-UPG

  • General-purpose ultrasound imaging system
LP9 R4 to R4.5 SW Conversion
GE Ultrasound Korea Ltd.
P9 R4 to R4.5 SW Conversion
In Commercial Distribution

  • 00195278464675 ()


  • General-purpose ultrasound imaging system
LP8 R4 to R4.5 SW Conversion
GE Ultrasound Korea Ltd.
P9 R4 to R4.5 SW Conversion
In Commercial Distribution

  • 00195278464651 ()


  • General-purpose ultrasound imaging system
LOGIQ P10 R4.5
GE Ultrasound Korea Ltd.
P10 R4.5
In Commercial Distribution

  • 00195278464644 ()


  • General-purpose ultrasound imaging system
LOGIQ P9 R4.5
GE Ultrasound Korea Ltd.
P9 R4.5
In Commercial Distribution

  • 00195278464637 ()


  • General-purpose ultrasound imaging system
LOGIQ P8 R4.5
GE Ultrasound Korea Ltd.
P8 R4.5
In Commercial Distribution

  • 00195278464613 ()


  • General-purpose ultrasound imaging system
LOGIQ E10s R3 OLED
GE Ultrasound Korea Ltd.
E10s R3 OLED
In Commercial Distribution

  • 00195278410245 ()


  • General-purpose ultrasound imaging system
LOGIQ E10s R3
GE Ultrasound Korea Ltd.
E10s R3
In Commercial Distribution

  • 00195278410221 ()


  • General-purpose ultrasound imaging system
LOGIQ Fortis LCD Console
GE Ultrasound Korea Ltd.
FORTIS LCD
In Commercial Distribution

  • 00195278405333 ()


  • General-purpose ultrasound imaging system
LOGIQ E10 R3 Console
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
E10 R3
In Commercial Distribution

  • 00195278384041 ()

  • Width: 585 Millimeter
  • Length: 901 Millimeter
  • Height: 1300 Millimeter


  • General-purpose ultrasound imaging system
LOGIQ P10 R4
GE Ultrasound Korea Ltd.
P10 R4
In Commercial Distribution

  • 00195278111265 ()


  • General-purpose ultrasound imaging system
LOGIQ P9 R4
GE Ultrasound Korea Ltd.
P9 R4
In Commercial Distribution

  • 00195278111258 ()


  • General-purpose ultrasound imaging system
LOGIQ P8 R4
GE Ultrasound Korea Ltd.
P8 R4
In Commercial Distribution

  • 00195278111241 ()


  • General-purpose ultrasound imaging system
No Description
GE Healthcare Austria GmbH & Co OG
E BT20 to BT21 UPG
In Commercial Distribution

  • 00195278077592 ()


  • General-purpose ultrasound imaging system
No Description
GE Ultrasound Korea Ltd.
S8 R3 OLED
In Commercial Distribution

  • 00195278029010 ()


  • General-purpose ultrasound imaging system
No Description
GE Healthcare Austria GmbH & Co OG
E8 BT21
In Commercial Distribution

  • 00195278016829 ()


  • General-purpose ultrasound imaging system
No Description
GE Healthcare Austria GmbH & Co OG
E10 BT21
In Commercial Distribution

  • 00195278016812 ()


  • General-purpose ultrasound imaging system
VOLUSON SWIFT+ CONSOLE ASSY
GE Ultrasound Korea Ltd.
SWIFT+
In Commercial Distribution

  • 00195278006820 ()


  • General-purpose ultrasound imaging system
Venue R3 MD eDelivery or Physical Upgrade
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R3 UPG
In Commercial Distribution

  • 00195278005830 ()


  • General-purpose ultrasound imaging system
Voluson Expert 22 BT25
GE Healthcare Austria GmbH & Co OG
Expert 22 BT25
In Commercial Distribution

  • 00195278770271 ()
5936104

  • General-purpose ultrasound imaging system
Voluson Expert 18 BT25
GE Healthcare Austria GmbH & Co OG
Expert 18 BT25
In Commercial Distribution

  • 00195278770226 ()
5936106

  • General-purpose ultrasound imaging system
Voluson Expert 20 BT25
GE Healthcare Austria GmbH & Co OG
Expert 20 BT25
In Commercial Distribution

  • 00195278770158 ()
5936105

  • General-purpose ultrasound imaging system
Invenia ABUS Prime
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
ABUS R2.5 Prime
In Commercial Distribution

  • 00195278756138 ()
H5023S2-H5013S2

  • General-purpose ultrasound imaging system
LOGIQ Totus HDU
GE Ultrasound Korea Ltd.
Totus HDU
In Commercial Distribution

  • 00195278724342 ()
H46222LT

  • General-purpose ultrasound imaging system
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