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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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Bakes common bile duct dilators, 9'', 11.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029395 ()
43-911

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 10.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029388 ()
43-910

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 1.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029371 ()
43-901

  • Urethral bougie, reusable
Large Acutrak 2® Common Inst. Platter
Acumed LLC
80-0871
In Commercial Distribution

  • 10806378045431 ()


  • General internal orthopaedic fixation system implantation kit
Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software.
ABYS MEDICAL
1.xx.xxx
In Commercial Distribution

  • 03760365550004 ()
H001-WEB001

  • Radiology DICOM image processing application software
No Description
W.H. Holden, Inc.
200-500-160
In Commercial Distribution

  • D9282005001600 ()


  • Dental rongeur
Mobile Device: A component of the Atmo Gas Capsule System used to initiate a study and upload the results via the Clinic App.
ATMO BIOSCIENCES LIMITED
09359921000318
In Commercial Distribution

  • 09359921000318 ()
MOB010-0000US

  • Panel computer
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
ROD TO ROD CONNECTOR - 3.5MM X 5.5MM - END TO END CLOSED, DOUBLE
CORELINK LLC
35255-50
In Commercial Distribution

  • M7253525550 ()
35255-50

  • Bone-screw internal spinal fixation system, non-sterile
ROD TO ROD CONNECTOR - 3.5MM X 3.5MM - END TO END CLOSED, DOUBLE
CORELINK LLC
35235-50
In Commercial Distribution

  • M7253523550 ()
35235-50

  • Bone-screw internal spinal fixation system, non-sterile
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