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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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Bender, Fixed Cross Link, Left
Kalitec Direct LLC
11-K01-5002
In Commercial Distribution

  • B07311K0150020 ()


  • Spinal rod bending system
T-Handle, Head Persuader, 5.5mm
Kalitec Direct LLC
11-K01-3019
In Commercial Distribution

  • B07311K0130190 ()


  • Spinal rod bending system
Sagittal Bender, Right
Kalitec Direct LLC
11-K01-3014
In Commercial Distribution

  • B07311K0130140 ()


  • Spinal rod bending system
Sagittal Bender, Left
Kalitec Direct LLC
11-K01-3013
In Commercial Distribution

  • B07311K0130130 ()


  • Spinal rod bending system
Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system
No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system
No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system
No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system
No Description
ARCSCAN, INC.
AS100
In Commercial Distribution

  • B017AS100 ()
AS100-120

  • Ophthalmic ultrasound imaging system
ZENITH 9000 SLIDE WIDE W/LOK
GF HEALTH PRODUCTS, INC.
ZZA99674-897
In Commercial Distribution

  • M368ZZA996748971 ()


  • Centralized patient monitor
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