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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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8MP Integrated Dual-screen Display
Shenzhen Beacon Display Technology Co., Ltd.
C83W+
In Commercial Distribution

  • 06970027820551 ()


  • Radiology picture archiving and communication system workstation
3MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C32SP+
In Commercial Distribution

  • 06970027820544 ()


  • Radiology picture archiving and communication system workstation
The Orpheus System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real time with video-conferencing capability during the broadcast. The Orpheus System is not intended to be used as a primary diagnostic system for mammography and any other radiology application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025001 ()
MVD-0001

  • Radiology picture archiving and communication system workstation
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
CHILI GmbH
4.88.0
In Commercial Distribution

  • 04260456230185 ()


  • Radiology picture archiving and communication system workstation
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
TECHLAB, INC.
T5032
Not in Commercial Distribution

  • 00857031002547 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
TECHLAB, INC.
T30408
In Commercial Distribution

  • 00857031002400 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403940
Not in Commercial Distribution

  • 08714729963820 ()
  • 08714729963813 ()

  • 910 um Diameter


  • General/multiple surgical laser system beam guide, single-use
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