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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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BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid - 00815381020963

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

14X17 Cassette for CR Reader - 00817100020476

CRF-CASSETTE-35X43-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CASCR3543
In Commercial Distribution

  • 00817100020476 ()


  • Digital imaging cassette

10X12 Cassette for CR Reader - 00817100020469

10X12 Cassette for CR Reader - R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CASCR2430
In Commercial Distribution

  • 00817100020469 ()


  • Digital imaging cassette

Konica Minolta Ultra Software - 00817100020407

ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution

  • 00817100020407 ()


  • Diagnostic x-ray digital imaging system workstation application software

CR Reader - 00817100020391

CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CRII60
In Commercial Distribution

  • 00817100020391 ()


  • Digital imaging cassette/phosphor plate

CR Reader - 00817100020360

AF CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
CR30
In Commercial Distribution

  • 00817100020360 ()


  • Digital imaging cassette/phosphor plate

Konica Minolta SW (Acquire) Ultra - 00817100020179

ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-02-01-000
In Commercial Distribution

  • 00817100020179 ()


  • Diagnostic x-ray digital imaging system workstation application software

DRX - Ascend System - 60889971029881

LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software

Vita CR System - 60889971024084

VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

  • Computed radiography digital imaging scanner

Vita LE CR System - 60889971006240

VITA LE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner
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