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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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DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978864818

DIRECTVIEW CR Cassett with PQ Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978864812 ()
  • 40889978864818 ()
8864811

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889978792128

DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889978792122 ()
  • 40889978792128 ()
8792129

  • Digital imaging cassette/storage phosphor screen, mammographic

CS 7400 - 40889978427969

CR SEMI-FIN PLATE PAN 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Cassette with PQ Screen - 40889978413511

DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 40889978336193

18X24CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978336197 ()
  • 40889978336193 ()
8336190

  • Digital imaging cassette/storage phosphor screen, mammographic

CS 7400 - 40889978214231

CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889978188341

18X24CM DVIEW CR MAMMO SCR EHR-M
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978188345 ()
  • 40889978188341 ()
8188344

  • Digital imaging cassette/storage phosphor screen, mammographic

PCD, VertaPlex - 07613252018315

Precision System Kit with Short Extension Tube and HV Bone Cement
STRYKER CORPORATION
0507589000
In Commercial Distribution

  • 37613252018316 ()
  • 07613252018315 ()
0507-589-000

  • Orthopaedic cement, non-antimicrobial

Aqueduct SED - ACCCARTV101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCARTL200

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-200L
In Commercial Distribution

  • ACCCARTL200 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
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