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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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RapidVac - 10884524001753

Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()


  • Surgical plume evacuation system

RapidVac - 10884524001555

Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()


  • Surgical plume evacuation system

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

Remote Control - 07290114064033

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Remote Control
In Commercial Distribution

  • 07290114064033 ()
700-006011-00

  • Depth electrode

Renishaw Non-XY frame Mechanical Set KIT - 27290114064044

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Renishaw Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290114064044 ()
700-020050-00

  • Depth electrode

Ruler - 07290114061322

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

  • 07290114061322 ()
215-001111-00

  • Depth electrode

Ruler and DBs holder thumb screw - 07290114061414

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Ruler and DBs holder thumb screw
In Commercial Distribution

  • 07290114061414 ()
344-001110-00

  • Depth electrode

SAFE® System Surgical Smoke Evacuator - 00850043007067

No Description
Hydrafacial LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • Surgical plume evacuation system

SCARLET AC-T INSTRUMENTATION - 07640151086435

Compaction base
SpineArt SA
SCA-IC 04 00-N
In Commercial Distribution

  • 07640151086435 ()
SCA-IC 04 00-N

  • Bone graft packing block

SI-LUTION Sacroiliac Joint Fusion System - B648C6158000

GRAFT PACKER
CURITEVA, INC.
C615-800
In Commercial Distribution

  • B648C6158000 ()


  • Bone graft packing block

SJM™ - 05414734007276

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0914
In Commercial Distribution

  • 05414734007276 ()

  • Length: 14 Centimeter
  • Width: 9 Centimeter
C0914

  • Cardiovascular patch, animal-derived

SJM™ - 05414734007269

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0510
In Commercial Distribution

  • 05414734007269 ()

  • Length: 10 Centimeter
  • Width: 5 Centimeter
C0510

  • Cardiovascular patch, animal-derived

SJM™ - 05414734007252

With EnCap Technology
ST. JUDE MEDICAL, INC.
C0205
In Commercial Distribution

  • 05414734007252 ()

  • Width: 2 Centimeter
  • Length: 5 Centimeter
C0205

  • Cardiovascular patch, animal-derived

SJM™ - 05414734054881

Pericardial Patch
ST. JUDE MEDICAL, INC.
C0405
In Commercial Distribution

  • 05414734054881 ()

  • Length: 5 Centimeter
  • Width: 4 Centimeter
C0405

  • Cardiovascular patch, animal-derived

SMOKE-E-VAC - 30845854061163

Surgical Smoke Plume Evacuator 100V-120V 50/60Hz
Conmed Corporation
PLVV120
In Commercial Distribution

  • 30845854061163 ()
PLVV120

  • Surgical plume evacuation system

STERIS - 00817688023524

ICM-000-0645 STERIS Foot Switch
I.C. MEDICAL, INC.
SSESEN03
In Commercial Distribution

  • 00817688023524 ()
SSESEN03

  • Surgical plume evacuation system

STERIS - 00817688023517

ICM-000-0644 STERIS Laser Sensor
I.C. MEDICAL, INC.
SSESEN02
In Commercial Distribution

  • 00817688023517 ()
SSESEN02

  • Surgical plume evacuation system

STERIS - 00817688023500

ICM-000-0643 STERIS RF Sensor, Shielded
I.C. MEDICAL, INC.
SSESEN01
In Commercial Distribution

  • 00817688023500 ()
SSESEN01

  • Surgical plume evacuation system

STERIS - 00817688023012

ICM-000-0606 STERIS Large Coconut Charcoal Output Filter, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL02
In Commercial Distribution

  • 00817688023012 ()
SSEFIL02

  • Surgical plume evacuation system

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
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