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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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No Description
ORANGE SURGICAL INSTRUMENTS, LLC
262B
Not in Commercial Distribution

  • B35400 ()
  • B354262B2 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
262B
Not in Commercial Distribution

  • B35400 ()
  • B354262B1 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600284-001
In Commercial Distribution

  • J00716002840011 ()
1600284-001

  • Dental power tool system handpiece, remotely-driven
No Description
W.H. Holden, Inc.
10-0825-55
In Commercial Distribution

  • D928100825550 ()


  • Dental rongeur
No Description
AB MEDICA
LIL-OPT-30
In Commercial Distribution

  • E496LILOPT300 ()
LIL-OPT-30

  • Rigid optical laparoscope
No Description
DETAX GmbH
02589
In Commercial Distribution

  • EDET025891 ()


  • Earmould, custom-made
Kit SST-A for the retrofitting of the Helmer PF48
BIOLOG-ID
01
In Commercial Distribution

  • B765PRD7150200 ()


  • Blood refrigerator/incubator
Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
DORSAVI LTD
30Min-DAP
In Commercial Distribution

  • B758000035630 ()
  • B758000RDA326 ()
0356-30

  • Psychophysiological biofeedback system
Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter, DI header, two pumps, and divert-to-drain. 208V.
BETTER WATER, LLC
WM-PST-303-RM-2GJ
In Commercial Distribution

  • PS0154 ()
WM-PST-303-RM-2GJ

  • Combination water purification system
Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter, DI header, two pumps, and divert-to-drain. 230V.
BETTER WATER, LLC
WM-PST-303-RM-2GD
In Commercial Distribution

  • PS0153 ()
WM-PST-303-RM-2GD

  • Combination water purification system
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