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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No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 0.5 cc
In Commercial Distribution

  • 00860010170106 ()


  • Synthetic bone graft
Tri panel radiation shield.
Rampart Ic, LLC
M1130-TPS
In Commercial Distribution

  • 00860010101247 ()
M1130-TPS

  • Radiation shielding panel, portable/mobile
Mobile Radiation Shield
Rampart Ic, LLC
M1128-RTV-02
In Commercial Distribution

  • 00860010101209 ()
M1128-RTV-2

  • Radiation shielding panel, portable/mobile
Zeitels Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable.
Endocraft, LLC
UMG100A
In Commercial Distribution

  • 00860009975149 ()
UMG100A

  • Laryngoscope handle, reusable
  • Laryngoscope blade, reusable
Zeitels Suspension Gallows positions and holds the laryngoscope and patient in ideal posture for surgery. This suspension mounts to the surgical bed, rather than on the patient's chest.
Endocraft, LLC
ZVG100A
In Commercial Distribution

  • 00860009975132 ()
ZVG100A

  • Rigid laryngoscope positioner
Zeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable. It is slimmer and designed geometrically to enhance access to tighter surgical sites.
Endocraft, LLC
SlimUMG100
In Commercial Distribution

  • 00860009975101 ()
SlimUMG100

  • Laryngoscope handle, reusable
  • Laryngoscope blade, reusable
No Description
Mv Life LLC
1400-5100
In Commercial Distribution

  • 00860009971103 ()


  • Stationary oxygen concentrator
A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution

  • 00860009958104 ()


  • Cognitive assessment software
No Description
Wheelhouse Medical
WM01-0041
In Commercial Distribution

  • 00860009952492 ()


  • Orthopaedic graft inserter, reusable
No Description
Wheelhouse Medical
WM01-0070
In Commercial Distribution

  • 00860009952485 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0069
In Commercial Distribution

  • 00860009952478 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0068
In Commercial Distribution

  • 00860009952461 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0067
In Commercial Distribution

  • 00860009952454 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0066
In Commercial Distribution

  • 00860009952447 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0065
In Commercial Distribution

  • 00860009952430 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0064
In Commercial Distribution

  • 00860009952423 ()


  • Bone curette, reusable
No Description
Wheelhouse Medical
WM01-0038
In Commercial Distribution

  • 00860009952416 ()


  • Orthopaedic graft inserter, reusable
No Description
Wheelhouse Medical
WM01-0037
In Commercial Distribution

  • 00860009952409 ()


  • Bone graft funnel
The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Radiopharmaceutical Imaging and Dosimetry, LLC
3DRD-001
In Commercial Distribution

  • 00860009926905 ()


  • Nuclear medicine system workstation
CMFlex Block for bone graft 38 x 38 x 9 (mm)
Dimension INX Corp
CMFB13
In Commercial Distribution

  • 00860009902008 ()
  • 10860009902005 ()
  • 30860009902009 ()
  • 20860009902002 ()

  • Length: 38 Millimeter
  • Width: 38 Millimeter
  • Height: 9 Millimeter


  • Synthetic bone graft
TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm
TendoNova Disposable Unit 80mm Kit-Single
Tendonova Corporation
DU1F80L-K
In Commercial Distribution

  • 00860009899858 ()

  • Length: 80 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Spiral blade
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
TendoNova Disposable Unit 60mm Kit
Tendonova Corporation
DU5F60L-K
In Commercial Distribution

  • 00860009899841 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing
Renalytix Ai, Inc.
RENX-3011087
In Commercial Distribution

  • 00860009877931 ()


  • General specimen collection kit
Test Report for the kidneyintelX.dkd test.
Renalytix Ai, Inc.
1
In Commercial Distribution

  • 00860009877924 ()


  • Kidney disease progression risk assessment interpretive software IVD
  • Multiple chronic kidney disease (CKD) marker IVD, kit, chemiluminescent immunoassay
Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Renalytix Ai, Inc.
RENX3011003
In Commercial Distribution

  • 00860009877917 ()


  • General specimen collection kit
Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX testing.
Renalytix Ai, Inc.
RENX-3011000
In Commercial Distribution

  • 00860009877900 ()


  • General specimen collection kit
Rectal Cleansing System
MORRIS MEDICAL, INC.
CW1000
In Commercial Distribution

  • 00860009877818 ()
  • 00860009877801 ()


  • Surgical irrigation/aspiration tubing set
No Description
Labcorp Genetics Inc
K-INV-PHLEBOTOMY-BN/000
In Commercial Distribution

  • 00860009842281 ()


  • Blood collection set, invasive
No Description
Labcorp Genetics Inc
K-INV-RNA / 000
In Commercial Distribution

  • 00860009842267 ()


  • General specimen collection kit IVD, clinical
No Description
Labcorp Genetics Inc
K-INV-N-CARRIER / 000
Not in Commercial Distribution

  • 00860009842236 ()
K-INV-N-CARRIER / 000

  • General specimen collection kit IVD, clinical
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages.
Videahealth, Inc.
VPA01BP
In Commercial Distribution

  • 00860009836815 ()


  • Dental x-ray image interpretive software
Patient-specific, Orthopedic Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
OTHAMNS
In Commercial Distribution

  • 00860009815773 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
OTHAMFEUS
In Commercial Distribution

  • 00860009815766 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Othopedic Anatomical Model, Digital
3D LIFEPRINTS UK LTD
OTHDAM
Not in Commercial Distribution

  • 00860009815742 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Anatomical Model, Digital
3D LIFEPRINTS UK LTD
CMFDAM
Not in Commercial Distribution

  • 00860009815735 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Surgical Guide
3D LIFEPRINTS UK LTD
CMFSG
In Commercial Distribution

  • 00860009815728 ()


  • Custom-made orthopaedic/craniofacial surgical guide
Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
CMFAMFEUS
In Commercial Distribution

  • 00860009815711 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
CMFAMNS
In Commercial Distribution

  • 00860009815704 ()


  • Custom-made organ/bone anatomy model
Integrity Orthopaedics Anchor Array
Integrity Orthopaedics, Inc
901002
In Commercial Distribution

  • 00860009782235 ()
901002

  • Tendon/ligament bone anchor, non-bioabsorbable
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