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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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Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
SONOMED, INC.
Ver 5
In Commercial Distribution

  • 00896100002002 ()
Axis

  • Ophthalmology PACS software
Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator
Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator
Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
Hybrid Dressing 10x40 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1040/5
In Commercial Distribution

  • 10849405002182 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
ECG Electrodes
Leonhard Lang GmbH
FS-TF1C /5
In Commercial Distribution

  • 30854661006465 ()
  • 20854661006468 ()
  • 10854661006461 ()
  • 00854661006464 ()
540C

  • Electrocardiographic electrode, single-use
ECG Electrodes
Leonhard Lang GmbH
FS-TB4 /5
In Commercial Distribution

  • 30854661006397 ()
  • 20854661006390 ()
  • 10854661006393 ()
  • 00854661006396 ()
754

  • Electrocardiographic electrode, single-use
ECG Electrodes
Leonhard Lang GmbH
FS-TF1C /5
Not in Commercial Distribution

  • 30854661006366 ()
  • 20854661006369 ()
  • 10854661006362 ()
  • 00854661006365 ()
540C

  • Electrocardiographic electrode, single-use
ECG Electrodes
Leonhard Lang GmbH
FS-TC1 /5
In Commercial Distribution

  • 30854661006212 ()
  • 20854661006215 ()
  • 10854661006218 ()
  • 00854661006211 ()
535

  • Electrocardiographic electrode, single-use
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