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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 - 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

Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID Kit - 05051700010368

No Description
THE BINDING SITE GROUP LIMITED
RK002
Not in Commercial Distribution

  • 05051700010368 ()


  • Total immunoglobulin M (IgM total) IVD, antibody
  • Total immunoglobulin A (IgA total) IVD, antibody
  • Total immunoglobulin G (IgG total) IVD, antibody

CARDINAL HEALTH - 10888439679137

KIT, G U MAJOR
Cardinal Health 200, LLC
PG5AMJKS4
In Commercial Distribution

  • 50888439679135 ()
  • 10888439679137 ()
PG5AMJKS4

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439663723

DR G FTM PACK
Cardinal Health 200, LLC
SBA22DGML7
In Commercial Distribution

  • 50888439663721 ()
  • 10888439663723 ()
SBA22DGML7

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439600841

KIT, G U MAJOR
Cardinal Health 200, LLC
PG5AMJKSO
In Commercial Distribution

  • 50888439600849 ()
  • 10888439600841 ()
PG5AMJKSO

  • Urological surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10888439610741

DR G FTM PACK
Cardinal Health 200, LLC
SBA22DGML6
In Commercial Distribution

  • 50888439610749 ()
  • 10888439610741 ()
SBA22DGML6

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439981858

G U MINOR PACK
Cardinal Health 200, LLC
SOT56GU19A
In Commercial Distribution

  • 50888439981856 ()
  • 10888439981858 ()
SOT56GU19A

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439976274

KIT, G U MAJOR
Cardinal Health 200, LLC
PU5AMJKSB
In Commercial Distribution

  • 50888439976272 ()
  • 10888439976274 ()
PU5AMJKSB

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10193489506754

MAJOR G/U PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0409376S
In Commercial Distribution

  • 10193489506754 ()
  • 40193489506755 ()
DYNJ0409376S

  • General surgical procedure kit, non-medicated, single-use

Colado CC - DIVO627532AN1

Colado CC 250 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627532AN
Not in Commercial Distribution

  • DIVO627532AN1 ()
627532AN

  • Dental casting non-noble alloy

Colado CC - DIVO627531AN1

Colado CC 1000 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627531AN
Not in Commercial Distribution

  • DIVO627531AN1 ()
627531AN

  • Dental casting non-noble alloy

Colado CC - DIVO627530AN1

Colado CC 25 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627530AN
Not in Commercial Distribution

  • DIVO627530AN1 ()
627530AN

  • Dental casting non-noble alloy
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