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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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OrthoGrid Hip Trauma - 00860003424841

OrthoGrid Trauma AI for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-507
In Commercial Distribution

  • 00860003424841 ()


  • Orthopaedic fluoroscopic grid software

Sontro Self-Fitting OTC Hearing Aids - 00850016231116

BEIGE/990011-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990011-SWH
In Commercial Distribution

  • 00850016231116 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231024

GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal

Vision 2 - 00817978020004

Salmonella O Polyvalent A-I Kit Group: A, B, C, D, E, F, G, H, I
PRO-LAB, INCORPORATED
PLA003
In Commercial Distribution

  • 00817978020004 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Annalise Triage - G140ANNALISECONTAINER70

CTB software versions 2.3+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
2.3+
In Commercial Distribution

  • G140ANNALISECONTAINER70 ()
Annalisecontainer7

  • Radiology DICOM image processing application software

Orfit Industries - 05420028783801

LOXON Set for Quantum table (set with two pieces)
Orfit Industries NV
33173
In Commercial Distribution

  • 05420028783801 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028707630

2-pin bar for Quantum couch 51.4 cm MR safe
Orfit Industries NV
33213
In Commercial Distribution

  • 05420028707630 ()


  • DNA-based tissue typing IVD, reagent

Natus - 00382830016391

Natus Quantum Breakout to Base Cable, 16 ft (5m)
XLTEK
013414
In Commercial Distribution

  • 00382830016391 ()


  • Electrical-only medical device connection cable, reusable

Natus - 00382830016384

Natus Quantum Breakout to Base Cable, 33 ft (10m)
XLTEK
013348
In Commercial Distribution

  • 00382830016384 ()


  • Electrical-only medical device connection cable, reusable

QW-420 - 60889974000085

QUANTUM 43 IN X 43 IN FIXED NO-TILT WS
CARESTREAM HEALTH, INC.
QW-420
In Commercial Distribution

  • 60889974000085 ()
AA3396

  • X-ray film cassette holder
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