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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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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

SAFE® System Surgical Smoke Evacuator - 00850043007067

No Description
Hydrafacial LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • Surgical plume evacuation system

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

Ruler - 07290114061322

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

  • 07290114061322 ()
215-001111-00

  • 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

Remote Control - 07290114064033

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

  • 07290114064033 ()
700-006011-00

  • Depth electrode

ReWalk(TM) Rehabilitaiton - 00861803000327

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

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

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

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
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