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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UPGRADE Vita Flex 30 to 45 PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971069443 ()
1069442

  • Computed radiography digital imaging scanner
NB Vita Flex CR 45PPH solution PC/Monito
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069412 ()
1069418

  • Computed radiography digital imaging scanner
NB Vita Flex CR 30PPH solution PC/Monito
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069405 ()
1069400

  • Computed radiography digital imaging scanner
Vita Flex CR 45PPH solution PC/Monitor
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069382 ()
1069384

  • Computed radiography digital imaging scanner
Vita Flex CR 30PPH solution PC/Monitor
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069375 ()
1069376

  • Computed radiography digital imaging scanner
Vita Flex CR System 45PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971069306 ()
1069301

  • Computed radiography digital imaging scanner
NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner
NB VITA CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971067692 ()
1067693

  • Computed radiography digital imaging scanner
NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner
Vita Flex CR System 30PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971067241 ()
1067248

  • Computed radiography digital imaging scanner
Max CR system
CARESTREAM HEALTH, INC.
Max CR System
In Commercial Distribution

  • 60889971056504 ()
1056506

  • Computed radiography digital imaging scanner
VITA LE CR SOLUTION W / PC AND MONITOR
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971054814 ()
1054816

  • Computed radiography digital imaging scanner
NON BRANDED VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036940 ()
1036946

  • Computed radiography digital imaging scanner
VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036933 ()
1036938

  • Computed radiography digital imaging scanner
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 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
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner
Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR
LED Dental Inc
Size 2 Replacement (A-Series)
In Commercial Distribution

  • 07540201000247 ()
6101AR

  • Dental digital imaging sensor, intraoral
Tuxedo Intraoral Sensor Size 1 (6100A Replacement) PN 6100AR
LED Dental Inc
Size 1 Replacement (A-Series)
In Commercial Distribution

  • 07540201000230 ()
6100AR

  • Dental digital imaging sensor, intraoral
Tuxedo Intraoral Sensor Size 2 (6101 Replacement) PN 6101R
LED Dental Inc
Size 2 Replacement
In Commercial Distribution

  • 07540201000223 ()
6101R

  • Dental digital imaging sensor, intraoral
Tuxedo Intraoral Sensor Size 1 (6100 Replacement)
LED Dental Inc
Size 1 Replacement
In Commercial Distribution

  • 07540201000216 ()
6100R

  • Dental digital imaging sensor, intraoral
No Description
LED Dental Inc
Size 2
In Commercial Distribution

  • 07540201000070 ()
6101, 6101A

  • Dental digital imaging sensor, intraoral
No Description
LED Dental Inc
Size 1
In Commercial Distribution

  • 07540201000063 ()
6100, 6100A

  • Dental digital imaging sensor, intraoral
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)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
CR MD4.0 GENERAL PLATE 14X51I.
AGFA
CR MD4.0 GENERAL PLATE 14X51
In Commercial Distribution

  • 05414904044100 ()

  • Width: 51 Inch
  • Length: 14 Inch
5O6MS

  • Digital imaging storage phosphor screen
CR MD4.0 GENERAL CASS HR 8X10I
AGFA
CR MD4.0 GENERAL CASSETTE 8x10
In Commercial Distribution

  • 05414904028971 ()

  • Width: 10 Inch
  • Length: 8 Inch
37PQH

  • Digital imaging cassette
POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini and BIOFIRE SPOTFIRE R/ST Panel
Mmqci
v.00
In Commercial Distribution

  • 00852720008091 ()
M42638

  • Multiple-genus respiratory virus nucleic acid IVD, control
An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6354
In Commercial Distribution

  • 00850051939299 ()
AW-EXT-LB

  • Sequential venous compression system
An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6154
In Commercial Distribution

  • 00850051939282 ()
AW-EXT-SB

  • Sequential venous compression system
No Description
Selux Diagnostics, Inc.
01-80001
In Commercial Distribution

  • 10850031114026 ()
  • 00850031114029 ()


  • Antimicrobial susceptibility analyser IVD
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution

  • 00857573006348 ()


  • Multiple coagulation factor IVD, kit, clotting
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
41
In Commercial Distribution

  • 00856181003411 ()


  • Headphones
No Description
THE BINDING SITE GROUP LIMITED
BP228
In Commercial Distribution

  • 05051700002059 ()


  • Kappa/lambda light chain immunoglobulin IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008077 ()
M416

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008060 ()
C130

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
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