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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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Dialyzer Dialysate QD to 45° Angle Hose Barb Red - 00858293006779

No Description
REPROCESSING PRODUCTS CORPORATION
D300-0105
In Commercial Distribution

  • 00858293006779 ()


  • Haemodialysis dialysate central supply system

Pump Spring, Strong - 00858293006762

No Description
REPROCESSING PRODUCTS CORPORATION
D300-0204
In Commercial Distribution

  • 10858293006769 ()
  • 00858293006762 ()


  • Haemodialysis dialysate central supply system

Pump Spring, Weak - 00858293006755

No Description
REPROCESSING PRODUCTS CORPORATION
D300-0203
In Commercial Distribution

  • 10858293006752 ()
  • 00858293006755 ()


  • Haemodialysis dialysate central supply system

SONOPRO - 00860009496903

SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.
Restec Solutions LLC
0002
In Commercial Distribution

  • 00860009496903 ()
SONO-0002

  • Atomized-chemical device disinfector

trophon2 - 09350855000184

High Level Disinfection System
NANOSONICS LIMITED
N05000-1
In Commercial Distribution

  • 09350855000184 ()
  • 09350855000191 ()


  • Atomized-chemical device disinfector

Trophon EPR - 09350855000122

Trophon US Refurbished
NANOSONICS LIMITED
N00010-US-RFB
In Commercial Distribution

  • 09350855000139 ()
  • 09350855000122 ()


  • Atomized-chemical device disinfector

Trophon EPR - 09350855000016

Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
NANOSONICS LIMITED
N00010-NNA
In Commercial Distribution

  • 09350855000115 ()
  • 09350855000016 ()


  • Atomized-chemical device disinfector

Trophon EPR - 09350855000009

Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
NANOSONICS LIMITED
N00010-US
In Commercial Distribution

  • 09350855000108 ()
  • 09350855000009 ()


  • Atomized-chemical device disinfector

NeuroPace® Remote Monitor Kit - 00855547005427

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
Neuropace, Inc.
5107
In Commercial Distribution

  • 00855547005434 ()
  • 00855547005427 ()


  • Brain-responsive electrical stimulation system

Explant Kit - 00855547005410

The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system

Remote Monitor Phone Accessories - 00855547005403

The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
Neuropace, Inc.
5104
In Commercial Distribution

  • 00855547005403 ()


  • Brain-responsive electrical stimulation system

Connector Cover Kit - 00855547005397

The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system

Craniectomy Template Kit - 00855547005380

The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system

Ferrule Kit - 00855547005373

The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005366

The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005366 ()


  • Brain-responsive electrical stimulation system

NeuroPace® Depth Lead Kit - 00855547005359

The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-344-3.5-K
In Commercial Distribution

  • 00855547005359 ()

  • Length: 44 Centimeter
  • 4 electrodes with 3.5 mm spacing


  • Brain-responsive electrical stimulation system

NeuroPace® Depth Lead Kit - 00855547005342

The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-3.5-K
In Commercial Distribution

  • 00855547005342 ()

  • 4 electrodes with 3.5 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system

NeuroPace® Depth Lead Kit - 00855547005335

The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-10-K
In Commercial Distribution

  • 00855547005335 ()

  • 4 electrodes with 10 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system

NeuroPace® Cortical Strip Lead Kit - 00855547005328

The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-315-10-K
In Commercial Distribution

  • 00855547005328 ()

  • Length: 15 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system

NeuroPace® Cortical Strip Lead Kit - 00855547005311

The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-325-10-K
In Commercial Distribution

  • 00855547005311 ()

  • 4 electrodes with 10 mm spacing
  • Length: 25 Centimeter


  • Brain-responsive electrical stimulation system

NeuroPace® Cortical Strip Lead Kit - 00855547005304

The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-335-10-K
In Commercial Distribution

  • 00855547005304 ()

  • Length: 35 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system

NeuroPace® Depth Lead Kit - 00855547005298

The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-344-10-K
In Commercial Distribution

  • 00855547005298 ()

  • Length: 44 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system

RNS® Tablet Kit - 00855547005281

The RNS® Tablet package contains 1 RNS® Tablet, 1 Stylus, 1 AC Adapter and 1 Carrying Case.
Neuropace, Inc.
5001
In Commercial Distribution

  • 00855547005274 ()
  • 00855547005281 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005267

The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system

NeuroPace® Remote Monitor Kit - 00855547005250

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, and 1 Ethernet (Network) Cable.
Neuropace, Inc.
5101
In Commercial Distribution

  • 00855547005243 ()
  • 00855547005250 ()


  • Brain-responsive electrical stimulation system

NeuroPace® Lead Accessory Kit - 00855547005229

The NeuroPace® Lead Accessory package contains 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge, 1 Tunneling Tool, 1 Tunneling Tool Tip and 1 Tunneling Tool Straw.
Neuropace, Inc.
LA-02-K
In Commercial Distribution

  • 00855547005229 ()


  • Brain-responsive electrical stimulation system

Ferrule Kit - 00855547005175

The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005175 ()


  • Brain-responsive electrical stimulation system

Craniectomy Template Kit - 00855547005168

The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005168 ()


  • Brain-responsive electrical stimulation system

Connector Cover Kit - 00855547005151

The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005151 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005120

The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • Brain-responsive electrical stimulation system
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