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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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NA - 04546540754387

9MM GRAFT SIZING GAUGE
STRYKER CORPORATION
234-010-002
In Commercial Distribution

  • 04546540754387 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
234-010-002

  • Ligament graft sizer, noninvasive

ScanNav Anatomy Peripheral Nerve Block - 05060878810052

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software

ScanNav Anatomy Peripheral Nerve Block - 05060878810021

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software

Angio Workstation Software - 04987670100451

Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution

  • 04987670100451 ()


  • Diagnostic x-ray digital imaging system workstation application software

NA - 10886705010943

LIGAMENT SIZING SCALE 0 - 13mm (Plus or Minus 3 Percent)
DEPUY MITEK, LLC
232013
Not in Commercial Distribution

  • 10886705010943 ()
232013

  • Ligament graft sizer, noninvasive

RESTORE - 10886705010950

RESTORE GRAFT SIZER 8-12mm (Plus or Minus 2 Percent)
Medos International Sàrl
232015
In Commercial Distribution

  • 10886705010950 ()
232015

  • Ligament graft sizer, noninvasive

NA - 10886705006519

Tendon and Graft Sizer 4-9mm Plus or Minus 3 Percent
Medos International Sàrl
219445
In Commercial Distribution

  • 10886705006519 ()
219445

  • Ligament graft sizer, noninvasive

NA - 10886705006502

GRAFT SIZER 5-12mm Plus or Minus 3 Percent
Medos International Sàrl
219444
In Commercial Distribution

  • 10886705006502 ()
219444

  • Ligament graft sizer, noninvasive

MITEK TIGHT-N - 10886705032716

MITEK TIGHT-N Tendon Docking Anchor Implant Sizer
Medos International Sàrl
208886
In Commercial Distribution

  • 10886705032716 ()
208886

  • Ligament graft sizer, noninvasive

n.a. - 04048551114728

Tendon Thickness Tester, 4-7 mm
Karl Storz GmbH & Co. KG
28729SD
In Commercial Distribution

  • 04048551114728 ()


  • Ligament graft sizer, noninvasive
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