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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SICAT OPTIMOTION
SiCAT GmbH & Co. KG
10501
In Commercial Distribution

  • D776105010 ()
10501

  • Custom-made mouthguard
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access + inflation device
Coloplast A/S
BD3020
In Commercial Distribution

  • 03600040325087 ()

  • Outer Diameter: 10 Millimeter
  • Length: 55 Centimeter
BD3020

  • Endoscopic-access dilator, single-use
In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access
Coloplast A/S
BD3010
In Commercial Distribution

  • 03600040325056 ()

  • Outer Diameter: 10 Millimeter
  • Length: 55 Centimeter
BD3010

  • Endoscopic-access dilator, single-use
Geenius SW V2.0 & APF V2.0 Installation Kit
Bio-RAD Laboratories, Inc.
12012851
In Commercial Distribution

  • 03610522168064 ()

  • 1 Each
12012851

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Software V2.0 LIS Guide, US only
Bio-RAD Laboratories, Inc.
12012484
In Commercial Distribution

  • 03610522162260 ()

  • 1 Each
12012484

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Blood Donor IFU & APF v2.0 binder
Bio-RAD Laboratories, Inc.
12012482
In Commercial Distribution

  • 03610522162239 ()

  • 1 each
12012482

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius HIV 1/2 Supplemental Assay 20t
Bio-RAD Laboratories, Inc.
72480
In Commercial Distribution

  • 03610521168942 ()

  • 20 Tests
72480

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
No Description
McKeon Products, Inc.
Nighttime Dental Guard
In Commercial Distribution

  • 00033732010306 ()
1030

  • Mouthguard, reusable
Kids Size Silicone Earplugs - 15 pair box - Orange
McKeon Products, Inc.
Kids Size Soft Moldable Silicone Putty Earplugs
In Commercial Distribution

  • 10033732010150 ()
  • 00033732010153 ()
1015

  • Earplugs, reusable
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