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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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Cambria NanoMetalene - 10889981093815

Cambria NM Graft Packer
SEASPINE ORTHOPEDICS CORPORATION
93-9832
In Commercial Distribution

  • 10889981093815 ()
93-9832

  • Bone graft packing block

Cambria - 10889981092924

Cambria Graft Packing Block, Universal
SEASPINE ORTHOPEDICS CORPORATION
93-9005
In Commercial Distribution

  • 10889981092924 ()
93-9005

  • Bone graft packing block

Cambria - 10889981092917

Cambria Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-9004
In Commercial Distribution

  • 10889981092917 ()
93-9004

  • Bone graft packing block

SeaSpine® Spacer System - Redondo - 10889981091392

Graft Packing Block 30mm x 24mm x XXmm
SEASPINE ORTHOPEDICS CORPORATION
93-6116
In Commercial Distribution

  • 10889981091392 ()

  • 30mm x 24mm x XXmm
93-6116

  • Bone graft packing block

SeaSpine® Spacer System - Redondo - 10889981091385

Graft Packing Block, 26mm
SEASPINE ORTHOPEDICS CORPORATION
93-6115
In Commercial Distribution

  • 10889981091385 ()

  • 26mm
93-6115

  • Bone graft packing block

SeaSpine Spacer System - Hollywood - 10889981089917

Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-4157
In Commercial Distribution

  • 10889981089917 ()
93-4157

  • Bone graft packing block

SeaSpine Spacer System - Pacifica - 10889981088309

Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3157
In Commercial Distribution

  • 10889981088309 ()
93-3157

  • Bone graft packing block

SeaSpine Spacer System - Pacifica - 10889981088293

Pacifica-S Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3156
In Commercial Distribution

  • 10889981088293 ()
93-3156

  • Bone graft packing block

SeaSpine Spacer System - Pacifica - 10889981088286

Pacifica Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3155
In Commercial Distribution

  • 10889981088286 ()
93-3155

  • Bone graft packing block

Sonoma - 10889981086763

Extractor Block
SEASPINE ORTHOPEDICS CORPORATION
92-0126
In Commercial Distribution

  • 10889981086763 ()
92-0126

  • Bone graft packing block

Shoreline ASC - 10889981127121

Implant Assembly/Packing block
SEASPINE ORTHOPEDICS CORPORATION
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block

Mariner - 10889981128876

Screw Sizing Block
SEASPINE ORTHOPEDICS CORPORATION
90-0530
In Commercial Distribution

  • 10889981128876 ()
90-0530

  • Bone graft packing block

Vu a-POD Prime NanoMetalene - 10889981125882

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
33-40-0141
In Commercial Distribution

  • 10889981125882 ()
33-40-0141

  • Bone graft packing block

Vu aPod™ - L - 10889981121471

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
31-40-0142
In Commercial Distribution

  • 10889981121471 ()
31-40-0142

  • Bone graft packing block

Zuma-C - 10889981120733

Zuma-C Universal Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7092
In Commercial Distribution

  • 10889981120733 ()

  • N/A
95-7092

  • Bone graft packing block

Zuma - 10889981120627

Graft Packing Block, 38mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
95-5193
In Commercial Distribution

  • 10889981120627 ()

  • 38mm x 26mm
95-5193

  • Bone graft packing block

Reef TO - 10889981195755

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • Bone graft packing block

Reef TA - 10889981213022

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • Bone graft packing block

Meridian - 10889981216535

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
RA2-006003
In Commercial Distribution

  • 10889981216535 ()
RA2-006003

  • Bone graft packing block

Specials - 10889981285364

Shoreline/Admiral Graft Packer
SEASPINE ORTHOPEDICS CORPORATION
SR-0755
In Commercial Distribution

  • 10889981285364 ()
SR-0755

  • Bone graft packing block

G-EO - 07640174420032

Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system

G-EO System - 07640174420018

Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system

Small Pacer - 00850001752244

Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual

Mini Pacer - 00850001752237

Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual

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

QIAstat-Dx® Respiratory Panel - 04053228033905

No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Health o meter professional - 00851628008066

Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic

PMT® CORPORATION - SPHENOIDAL - 10650551092992

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09-NS
In Commercial Distribution

  • 10650551092992 ()
  • 00650551092995 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-09-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092954

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03-NS
In Commercial Distribution

  • 10650551092954 ()
  • 00650551092957 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092930

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03-NS
In Commercial Distribution

  • 10650551092930 ()
  • 00650551092933 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092916

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03-NS
In Commercial Distribution

  • 10650551092916 ()
  • 00650551092919 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092879

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122NS
In Commercial Distribution

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092855

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092831

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092824

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092800

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092961

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05-NS
In Commercial Distribution

  • 10650551092961 ()
  • 00650551092964 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-05-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092893

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03-NS
In Commercial Distribution

  • 10650551092893 ()
  • 00650551092896 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092862

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092848

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092817

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode

sEEG DEPTHALON - 00650551148722

PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-170-NS
In Commercial Distribution

  • 00650551148722 ()


  • Depth electrode

sEEG DEPTHALON - 00650551148715

PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-169-NS
In Commercial Distribution

  • 00650551148715 ()


  • Depth electrode

DEPTHALON - 00650551148241

PLATINUM DEPTH ELECTRODE, 10 MACRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-10-036-NS
In Commercial Distribution

  • 00650551148241 ()


  • Depth electrode

DEPTHALON - 00650551147947

PLATINUM MICROWIRE ELECTRODE, 8 MACRO CONTACTS 8 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2104-08-08-001
In Commercial Distribution

  • 00650551147947 ()


  • Depth electrode
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