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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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Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy. The software provides a range of features, including: - 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP). - 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering. - Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning. - Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices. The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution

  • 08800019700593 ()


  • General-purpose dental x-ray system application software
Lubricated Male Latex Condom
GLOBAL PROTECTION CORP.
110200C
In Commercial Distribution

  • 20726893111725 ()
  • 80726893111727 ()


  • Basic male condom, Hevea-latex
Filter and check valve; one end barb, one end Luer.
SOMAVAC MEDICAL SOLUTIONS, INC.
20031
In Commercial Distribution

  • 00850004219034 ()
  • 10850004219031 ()
20031

  • Closed-wound drain connection tubing set
Array electrode carrier and clamp, one shielded and one non-shielded
FHC, INC.
66-AC-AR-00525
In Commercial Distribution

  • 00873263005255 ()
66-AC-AR

  • Neurosurgical micro targeting drive
Hemosure hCG Controls Set 2mL. One positive and one negative.
HEMOSURE INC.
F2-TC01
Not in Commercial Distribution

  • 00857338006262 ()
F2-TC01

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
CHERRY S-SHAPE BRAIN RETRACTOR . ONE END WIDE ONE END WIDE
Avalign Technologies, Inc.
1-51350
In Commercial Distribution

  • 00190776167103 ()


  • Hand-held surgical retractor, reusable
Johnson Band Contouring Pliers, One Convex and One Concave Tip
Surgical Direct, Inc.
SD93645201
In Commercial Distribution

  • B382SD936452010 ()
SD93645201

  • Dental elevator, tooth/root
VSP SPINE SYSTEM A-SLOT PLATE, ONE AND ONE HALF SLOT
DEPUY SPINE, LLC
222515A
Not in Commercial Distribution

  • 10705034240763 ()
222515A

  • Spinal fixation plate, non-bioabsorbable
Combination Mallet, One Nylon Cap and One Solid Stainless Side
Avalign Technologies, Inc.
1-250399
In Commercial Distribution

  • 00190776296445 ()


  • Surgical mallet
one side serrated, one side lancett 10 mm, 21.5 cm
Spiggle & Theis Medizintechnik GmbH
40-388-21
In Commercial Distribution

  • 04250381888445 ()
40-388-21

  • Cytology scraper, reusable
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