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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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SAFIRA - 05060727270037

Sterile SAFIRA 20 mL syringe (Luer)
MEDOVATE LIMITED
SAFIRA Syringe
In Commercial Distribution

  • 35060727270038 ()
  • 05060727270037 ()
900016

  • Pain management medication delivery system

SAFIRA - 05060727270020

SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system

SAFIRA - 05060727270013

SAFIRA system foot operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Foot Pedal
In Commercial Distribution

  • 05060727270013 ()
900044

  • Pain management medication delivery system

STRADIS HEALTHCARE - M75257032370

No Description
STRADIS MEDICAL, LLC
570-3237
In Commercial Distribution

  • M75257032370 ()


  • Pain management medication delivery system

Hands Free Syringe - 00850316008036

Hands Free Syringe reusable foot pedal, 1 unit per box
BLUEFIN MEDICAL LLC
HFS-PDL
In Commercial Distribution

  • 00850316008036 ()
412072-001

  • Pain management medication delivery system

Hands Free Syringe - 00850316008029

Hands Free Syringe limited reuse motor housing, 1 unit per box
BLUEFIN MEDICAL LLC
HFS-HOU
In Commercial Distribution

  • 00850316008029 ()
412071-001

  • Pain management medication delivery system

Hands Free Syringe - 00850316008005

Hands Free Syringe single-use sterile syringe
BLUEFIN MEDICAL LLC
HFS-SYR
In Commercial Distribution

  • 00850316008012 ()
  • 00850316008005 ()
412073-001

  • Pain management medication delivery system

Hands Free Syringe - 00814384020413

1 Motor Housing unit that injects/aspirates the HFS Sterile Syringe
CONCERT MEDICAL, LLC
HFS-HOU
In Commercial Distribution

  • 00814384020413 ()
411984-001

  • Pain management medication delivery system

Hands Free Syringe - 00814384020406

1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe.
CONCERT MEDICAL, LLC
HFS-PDL
In Commercial Distribution

  • 00814384020406 ()
411983-001

  • Pain management medication delivery system

Hands Free Syringe - 00814384020383

Pouch of 1 sterile 20 mL syringe, stored inside a box of 20
CONCERT MEDICAL, LLC
HFS-SYR
In Commercial Distribution

  • 00814384020383 ()
  • 00814384020390 ()
411987-001

  • Pain management medication delivery system
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