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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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IR 14X17 Portable GOS Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN240
In Commercial Distribution

  • 00817100020230 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN221
In Commercial Distribution

  • 00817100020223 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN220
In Commercial Distribution

  • 00817100020216 ()


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
Imaging Dynamics Company Ltd
1417WC
In Commercial Distribution

  • 00823073003217 ()

  • Height: 15.9 Millimeter
  • Width: 417 Millimeter
  • Length: 460 Millimeter
  • Weight: 3.5 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector.
Imaging Dynamics Company Ltd
1717TC
In Commercial Distribution

  • 00823073002111 ()

  • Height: 15.5 Millimeter
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Weight: 4.0 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Detector.
Imaging Dynamics Company Ltd
1417WCI
In Commercial Distribution

  • 00823073005211 ()

  • Weight: 3.6 Kilogram
  • Height: 15.2 Millimeter
  • Width: 384 Millimeter
  • Length: 460 Millimeter


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
Imaging Dynamics Company Ltd
1717WCI
In Commercial Distribution

  • 00823073005112 ()

  • Height: 15.1 Millimeter
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Weight: 4.67 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Motion Mobile DR Retrofit Kit
CARESTREAM HEALTH, INC.
CARESTREAM DRX-Mobile Retrofit Kit
Not in Commercial Distribution

  • 60889971740366 ()
1740364

  • Diagnostic x-ray digital imaging conversion system
FLAT TAPE ON GRID FOR 25X30 DETECTOR
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System Detector
In Commercial Distribution

  • 60889971054968 ()
1054964

  • Diagnostic x-ray digital imaging conversion system
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-01041
In Commercial Distribution

  • 00884838065239 ()
712090

  • Diagnostic x-ray digital imaging conversion system
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-01041
In Commercial Distribution

  • 00884838074538 ()
712090

  • Diagnostic x-ray digital imaging conversion system
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
CAPTION HEALTH, INC.
Apollo
In Commercial Distribution

  • 00860003586334 ()
511-00021

  • Ultrasound imaging system application software
SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973.
SONOCINE, INC.
Model 201
In Commercial Distribution

  • B3015017750001 ()
501775000

  • Breast ultrasound imaging system
No Description
CLINICOMP INTERNATIONAL, INC.
UDAS17
In Commercial Distribution

  • B321598107300 ()

  • Weight: 1.13 Pound
  • Depth: 1.875 Inch
  • Height: 4.5 Inch
  • Width: 8.25 Inch


  • Centralized patient monitor
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Alligator Clip, Red (1) Alligator Clip, Black Length 60” (152 cm)
Kego Corporation
KM-PA051060RB
In Commercial Distribution

  • 00663427000406 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Alligator Clip, Red (1) Alligator Clip, Black Length 40” (102 cm)
Kego Corporation
KM-PA051040RB
In Commercial Distribution

  • 00663427000390 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Red Alligator Clip (1) Green Alligator Clip (1) Black Male Shrouded TP Connector Length 40” (102 cm)
Kego Corporation
KM-PA050540RG
In Commercial Distribution

  • 00663427000383 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Red Alligator Clip (1) Black Male Shrouded TP Connector Length 40” (102 cm)
Kego Corporation
KM-PA050540R
In Commercial Distribution

  • 00663427000376 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to 3X Male Shrouded TP Connectors Red/Green/Black Length 40” (102 cm)
Kego Corporation
KM-PA05124RBG
In Commercial Distribution

  • 00663427000345 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to 2 X Male Shrouded TP Connectors Red/Black Length 40” (102 cm)
Kego Corporation
KM-PA05124RB
In Commercial Distribution

  • 00663427000338 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Alligator Clip, Red (1) Alligator Clip, Green (1) Alligator Clip, Black Length 60” (152 cm)
Kego Corporation
KM-PA05116RBG
In Commercial Distribution

  • 00663427000321 ()


  • Electrocardiographic lead set, reusable
KING Shielded Acquisition Cable 5 PIN DIN Connector to (1) Alligator Clip, Red (1) Alligator Clip, Green (1) Alligator Clip, Black Length 40” (102 cm)
Kego Corporation
KM-PA05114RBG
In Commercial Distribution

  • 00663427000314 ()


  • Electrocardiographic lead set, reusable
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000230 ()


  • Radiological PACS software
CUSTOM PACK TL8F19R 5PK SUCKERS CO
MEDTRONIC, INC.
TL8F19R
In Commercial Distribution

  • 20643169449095 ()
  • 00643169449091 ()


  • Cardiopulmonary bypass system blood tubing set
*CUSTOM* Shelby Co Blood Draw Kit
BOUND TREE MEDICAL, LLC
8600-01331
In Commercial Distribution

  • 00812277031959 ()
  • 00810094572792 ()
8600-01331

  • Arterial blood sampling kit
324.211 @PERCUTANEOUS DRL BIT, QK CO
MEDLINE INDUSTRIES, INC.
324211RH
In Commercial Distribution

  • 10888277334700 ()
324211RH

  • Cannulated surgical drill bit, single-use
KENDALL DL DISPOSABLE DRAEGER DIRECT CO
MEDLINE INDUSTRIES, INC.
33132R
In Commercial Distribution

  • 40888277313119 ()
  • 10888277313118 ()
33132R

  • Electrocardiographic lead set, reprocessed
AR-1223CC CENTERING CYLINDER FOR 9MM CO
MEDLINE INDUSTRIES, INC.
AR1223CCRH
In Commercial Distribution

  • 10888277383098 ()
AR1223CCRH

  • Bone-resection orthopaedic reamer, reprocessed
310.88 @COUNTERSINK FOR 1.5MM & 2.0MM CO
MEDLINE INDUSTRIES, INC.
31088RH
In Commercial Distribution

  • 10888277373754 ()
31088RH

  • Fluted surgical drill bit, single-use
Screwdriver Duo, T15, quick co upling
aap Implantate AG
IU 7825-56
In Commercial Distribution

  • 04042409361401 ()


  • Surgical screwdriver, reusable
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