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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

WAVE - 09336472008802

WAVE 1 SYR G
SDI LIMITED
7514143
In Commercial Distribution

  • 09336472008802 ()
7514143

  • Dental composite resin

CARDINAL HEALTH - 10888439232868

R E G PACK
Cardinal Health 200, LLC
SEY41RPAV5
In Commercial Distribution

  • 50888439232866 ()
  • 10888439232868 ()
SEY41RPAV5

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

CARDINAL HEALTH - 10888439075144

PODIATRY KIT F G
Cardinal Health 200, LLC
SOP14FTRG1
In Commercial Distribution

  • 50888439075142 ()
  • 10888439075144 ()
SOP14FTRG1

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

CARDINAL HEALTH - 10888439161212

KIT,THORACOTOMY THORACOSCOPY G
Cardinal Health 200, LLC
PV41TTNWC
In Commercial Distribution

  • 50888439161210 ()
  • 10888439161212 ()
PV41TTNWC

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

PRIMUS Sterilizer - 00850005738190

Steam Sterilizer, Healthcare, G
Primus Sterilizer Company, LLC
PSS8-G-M
In Commercial Distribution

  • 00850005738190 ()


  • Steam sterilizer

PRIMUS Sterilizer - 00850005738077

Steam Sterilizer, Healthcare, G
Primus Sterilizer Company, LLC
PSS5-G-M
In Commercial Distribution

  • 00850005738077 ()


  • Steam sterilizer

CARDINAL HEALTH - 10888439436167

R E G PACK
Cardinal Health 200, LLC
SEY41RPAV6
In Commercial Distribution

  • 50888439436165 ()
  • 10888439436167 ()
SEY41RPAV6

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

CARDINAL HEALTH - 10888439284591

EYE,STRL,F G
Cardinal Health 200, LLC
SEY53BSCR1
In Commercial Distribution

  • 50888439284599 ()
  • 10888439284591 ()
SEY53BSCR1

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

BioUniversal E - D7075925340

BioUniversal E 100 g
IVOCLAR VIVADENT, INC.
592534
Not in Commercial Distribution

  • D7075925340 ()
592534

  • Dental casting noble alloy

BioUniversal E - D7075925330

BioUniversal E 50 g
IVOCLAR VIVADENT, INC.
592533
Not in Commercial Distribution

  • D7075925330 ()
592533

  • Dental casting noble alloy

BioUniversal E - D7075925310

BioUniversal E 25 g
IVOCLAR VIVADENT, INC.
592531
Not in Commercial Distribution

  • D7075925310 ()
592531

  • Dental casting noble alloy

BioUniversal E - D7075925290

BioUniversal E 5 g
IVOCLAR VIVADENT, INC.
592529
Not in Commercial Distribution

  • D7075925290 ()
592529

  • Dental casting noble alloy

Evolution Lite - D7075836550

Evolution Lite 100 g
IVOCLAR VIVADENT, INC.
583655
In Commercial Distribution

  • D7075836550 ()
583655

  • Dental casting noble alloy

Evolution Lite - D7075836530

Evolution Lite 25 g
IVOCLAR VIVADENT, INC.
583653
In Commercial Distribution

  • D7075836530 ()
583653

  • Dental casting noble alloy

Evolution Lite - D7075836510

Evolution Lite 5 g
IVOCLAR VIVADENT, INC.
583651
In Commercial Distribution

  • D7075836510 ()
583651

  • Dental casting noble alloy

Ceramic W - D7075833320

Ceramic W 25 g
IVOCLAR VIVADENT, INC.
583332
Not in Commercial Distribution

  • D7075833320 ()
583332

  • Dental casting noble alloy

XLX - D7075833210

XL-X Plus 25 g
IVOCLAR VIVADENT, INC.
583321
Not in Commercial Distribution

  • D7075833210 ()
583321

  • Dental casting noble alloy

Sagittarius - D7075830550

Solarcast 20 50 g
IVOCLAR VIVADENT, INC.
583055
Not in Commercial Distribution

  • D7075830550 ()
583055

  • Dental casting noble alloy

MidiGold 52 - D7075830480

Midigold 50 100 g
IVOCLAR VIVADENT, INC.
583048
In Commercial Distribution

  • D7075830480 ()
583048

  • Dental casting noble alloy

MidiGold 54 - D7075830460

Midigold 50 25 g
IVOCLAR VIVADENT, INC.
583046
In Commercial Distribution

  • D7075830460 ()
583046

  • Dental casting noble alloy
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