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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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Specimen Cups With Leak Proof Screw on Lids - 3.5oz 500
Avaline Medical NJ Limited Liability Company
Sc3.5 x 500
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213469 ()
Sc3.5 x 500

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 100
Avaline Medical NJ Limited Liability Company
Sc3.5 x 100
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213452 ()
Sc3.5 x 100

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 50
Avaline Medical NJ Limited Liability Company
Sc3.5 x 50
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213445 ()
Sc3.5 x 50

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 25
Avaline Medical NJ Limited Liability Company
Sc3.5 x 25
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213438 ()
Sc3.5 x 25

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 4oz [Pack of 5] Non-Sterile Urine Sample Containers
Avaline Medical NJ Limited Liability Company
nssc x 5
In Commercial Distribution

  • 00850025452618 ()
  • 00810077212745 ()
nssc x 5

  • Urine specimen collection kit IVD
Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
Covidien LP
CB-CO-4 x 5
Not in Commercial Distribution

  • 20884521140209 ()
  • 10884521140202 ()
  • 30884521140206 ()

  • Width: 4 Inch
  • Length: 15 Feet
CB-CO-4 x 5

  • Wound compression dressing
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
Subtle Medical, Inc.
2.x
In Commercial Distribution

  • 00860000171212 ()


  • Radiology DICOM image processing application software
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).
Subtle Medical, Inc.
2.x
In Commercial Distribution

  • 00860000171205 ()


  • Radiology DICOM image processing application software
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution

  • 00860007599118 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution

  • 00860007599101 ()


  • Pathology information system
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