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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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STERIS - 00817688022992

ICM-000-0604 STERIS Hydrophobic ULPA Filter with Built-in Fluid Trap, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL01
In Commercial Distribution

  • 00817688023005 ()
  • 00817688022992 ()
SSEFIL01

  • Surgical plume evacuation system

STERIS - 00817688022985

ICM-460-0001 STERIS Smoke Evacuation System
I.C. MEDICAL, INC.
SSECAPREG
In Commercial Distribution

  • 00817688022985 ()
SSECAPREG

  • Surgical plume evacuation system

STERIS - 00817688022978

ICM-450-0001 STERIS Smoke Evacuation System Plus
I.C. MEDICAL, INC.
SSECAPPLS
In Commercial Distribution

  • 00817688022978 ()
SSECAPPLS

  • Surgical plume evacuation system

SaftEvac - 00609960001302

EVACUATOR, SAFTEVAC, 110 VOLT
DERMATOLOGIC LAB AND SUPPLY, INC.
EV-I
In Commercial Distribution

  • 00609960001302 ()
EV-I

  • Surgical plume evacuation system

Sage Cervical Interbody Fusion System - B648C2053100

Graft Packer
CURITEVA, INC.
C205-310
In Commercial Distribution

  • B648C2053100 ()


  • Bone graft packing block

Sage Cervical Interbody Fusion System - B648C2053000

Graft Packing Block
CURITEVA, INC.
C205-300
In Commercial Distribution

  • B648C2053000 ()


  • Bone graft packing block

Sample Tube 5 mL - 17350025914579

No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube

Savant Lumbar Interbody Fusion System - B648C4057000

TLIF Graft Packing Block
CURITEVA, INC.
C405-700
In Commercial Distribution

  • B648C4057000 ()


  • Bone graft packing block

Savant Lumbar Interbody Fusion System - B648C3057000

PLIF Graft Packing Block
CURITEVA, INC.
C305-700
In Commercial Distribution

  • B648C3057000 ()


  • Bone graft packing block

Savant Lumbar Interbody Fusion System - B648C2553000

ALIF Graft Packing Block
CURITEVA, INC.
C255-300
In Commercial Distribution

  • B648C2553000 ()


  • Bone graft packing block

Screwdriver - 07290114061308

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Screwdriver
In Commercial Distribution

  • 07290114061308 ()
365-000015-00

  • Depth electrode

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Skytron - 10841736100810

Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system

Skytron - 10841736100773

Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system

Skytron Smoke Evacuation - 10841736114992

Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system

Smoke Shark III - 10845854600092

Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system

Smoke Shark III - 10845854600085

Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system

Spencer Depth Probe Electrode - 00841823104236

No Description
Ad-Tech Medical Instrument Corporation
LD14R-SP05X-000
In Commercial Distribution

  • 00841823104236 ()
LD14R-SP05X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104229

No Description
Ad-Tech Medical Instrument Corporation
LD12R-SP05X-000
In Commercial Distribution

  • 00841823104229 ()
LD12R-SP05X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104212

No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP45X-000
In Commercial Distribution

  • 00841823104212 ()
LD10R-SP45X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104205

No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP05X-000
In Commercial Distribution

  • 00841823104205 ()
LD10R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823100412

No Description
Ad-Tech Medical Instrument Corporation
AD08R-SP05X-000
In Commercial Distribution

  • 00841823100412 ()
AD08R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823100405

No Description
Ad-Tech Medical Instrument Corporation
AD06R-SP05X-000
In Commercial Distribution

  • 00841823100405 ()
AD06R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823100399

No Description
Ad-Tech Medical Instrument Corporation
AD04R-SP10X-000
In Commercial Distribution

  • 00841823100399 ()
AD04R-SP10X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109514

No Description
Ad-Tech Medical Instrument Corporation
SD07R-SP45X-0T0
In Commercial Distribution

  • 00841823109514 ()
SD07R-SP45X-0T0

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109507

No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP45X-000
In Commercial Distribution

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109491

No Description
Ad-Tech Medical Instrument Corporation
SD16R-SP05X-000
In Commercial Distribution

  • 00841823109491 ()
SD16R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109484

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP45X-0T1
In Commercial Distribution

  • 00841823109484 ()
SD14R-SP45X-0T1

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109477

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109460

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP03X-000
In Commercial Distribution

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode
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