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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For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.5
In Commercial Distribution

  • 07350092810333 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.4
In Commercial Distribution

  • 07350092810289 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.3
In Commercial Distribution

  • 07350092810241 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.2
In Commercial Distribution

  • 07350092810197 ()


  • Pathology information system
K0360 ESR TRY BUY KIT 1P
Peter Brasseler Holdings, LLC
5026814U0
In Commercial Distribution

  • 00887919811824 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
PillCam™ WS v9 Dell T5810, USA
Given Imaging, Inc.
FGS-0640
In Commercial Distribution

  • 07290110360221 ()


  • Video capsule endoscopy system application software
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).
Guangdong JINME Medical Technology Co., Ltd.
T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP
In Commercial Distribution

  • 06971119540012 ()


  • Dental power tool system handpiece, pneumatic
Buy Me a Shot I'm Tying the Knot Condoms, Bag of 50 MTO
GLOBAL PROTECTION CORP.
BKU62
In Commercial Distribution

  • 80726893118856 ()
  • 00726893118850 ()


  • Basic male condom, Hevea-latex
WS, Dell T5810 V8.3 US
Given Imaging, Inc.
FGS-0600
In Commercial Distribution

  • 07290101366478 ()


  • Video capsule endoscopy system application software
WS, Dell T5810 V8.0 US
Given Imaging, Inc.
FGS-0599
In Commercial Distribution

  • 07290101366461 ()


  • Video capsule endoscopy system application software
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