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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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Alpha-Cal® is a calcium hydroxide paste with Barium Sulfate used as a root canal sealer for the temporary filling of root canals after conventional endodontic treatments. Alpha-Cal® is an aqueous, radiopaque, high pH (>12.0) paste packaged in a syringe ready to be dispensed through disposable tips into the root canal. Kit Contains: 4 x 1g Syringe, 8 Syringe Tips
DENTAL TECHNOLOGIES, INC.
414.0000.002
In Commercial Distribution

  • D73541400000020 ()
  • D73541402020020 ()
414.0000.002

  • Endodontic filling/sealing material
The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.
BAEBIES, INC.
2188
In Commercial Distribution

  • 00819704020197 ()
2188

  • Multichannel clinical chemistry analyser IVD, laboratory
The Camera Sleeve is used to create a sterile field around the video system camera head and cable
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3900
In Commercial Distribution

  • 35051223000878 ()
  • 05051223000877 ()

  • 2.5m long x 100mm diameter
PS3900

  • Camera cover, single-use
A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such as Epic S-Series.
Biolase, Inc.
E4-60 EZTip
In Commercial Distribution

  • 00647529001868 ()
  • 00647529000397 ()

  • Length: 60 Millimeter
  • Outer Diameter: 400 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex
Single use covers that provide a barrier to prevent cross contamination between patients when using the bite block.
AIR TECHNIQUES, INC.
A7395
In Commercial Distribution

  • D678A739510 ()


  • Cable/lead/sensor/probe cover, non-sterile
The camera sleeve is used to create a sterile field around the video system camera head and cable.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3901
In Commercial Distribution

  • 15051223029202 ()
  • 35051223029206 ()
  • 55051223029200 ()

  • 2.5m long x 100mm diameter
PS3901

  • Camera cover, single-use
The Nutritone Facial Beauty System is a gentle rejuvenating treatment which provides your skin with gentle electronic stimulation.
Isomers Laboratories Inc
T300
In Commercial Distribution

  • 00884785000017 ()


  • Radio-frequency skin surface treatment system
Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLA
In Commercial Distribution

  • 00817439020826 ()
HCGCTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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