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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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KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 size 10. Sterilized by Gamma Irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895181108 ()
  • 08902895181104 ()
18189

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Carbon steel Surgical Blade box of 100 size 10. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895180101 ()
  • 08902895180107 ()
18010

  • Manual scalpel blade, single-use
Kiato Sterile Disposable scalpel Stainless Steel box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895148101 ()
  • 08902895148107 ()
14810

  • Scalpel, single-use
KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895129100 ()
  • 08902895129106 ()
12910

  • Scalpel, single-use
KIATO Sterile CE carbon Steel Surgical Blade Box of 100 size 10. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 08902895111101 ()
  • 28902895111105 ()
11110

  • Manual scalpel blade, single-use
No Description
DEXIS LLC
10
In Commercial Distribution

  • EKAV100879340 ()
1.008.7934

  • Radiology information system application software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution

  • 00860461001776 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
10
In Commercial Distribution

  • 00856181003107 ()


  • MRI system coil, radio-frequency
Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007085 ()


  • Patient health record information system application software
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
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