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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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REFINEMENT CORRECTION
Access Dental Lab, LLC
100-0012
In Commercial Distribution



  • Orthodontic progressive aligner
Mid-Course Correction aligners
Access Dental Lab, LLC
100-0010
In Commercial Distribution



  • Orthodontic progressive aligner
Sequential -initial
Access Dental Lab, LLC
100-0352
In Commercial Distribution



  • Orthodontic progressive aligner
PNEUMOSTOP® PLUS DEVICE
LSI Solutions, Inc.
110230
In Commercial Distribution

  • 10850012846014 ()
  • 00850012846017 ()
  • 40850012846015 ()
  • 00850200006759 ()
110230

  • Laparoscopic hysterectomy vaginal occluder
PNEUMOSTOP® DEVICE
LSI Solutions, Inc.
110200
In Commercial Distribution

  • 10850012846007 ()
  • 00850012846000 ()
  • 40850012846008 ()
  • 00850200006742 ()
110200

  • Laparoscopic hysterectomy vaginal occluder
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
In Commercial Distribution



  • MRI image interpretive software
LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy
Lina Medical ApS
OP-201-6
In Commercial Distribution

  • 05708265013913 ()
  • 05708265013906 ()
  • 05708265013401 ()


  • Rigid video hysteroscope
Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
KEY SURGICAL, INC.
Cautery Tip Cleaner
In Commercial Distribution

  • 10849771052897 ()
  • 00849771052890 ()
  • 00849771030492 ()
TC200

  • Electrosurgical tip cleaning pad
Flexistem Ultrafine Cleaner, 6mil. x 6and#039; Roll
KEY SURGICAL, INC.
Pipe Cleaner
In Commercial Distribution

PC606

  • Surgical instrument/endoscope cleaning utensil, single-use
Pipe Cleaner, 1/4-inch Polyester, 50 feet
KEY SURGICAL, INC.
Pipe Cleaner
In Commercial Distribution


  • Outer Diameter: 0.25 Inch
PC400P

  • Surgical instrument/endoscope cleaning utensil, single-use
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