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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 - 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

Stainless Steel - 10889981114640

Screw Sizing Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0165
In Commercial Distribution

  • 10889981114640 ()
25-40-0165

  • Bone graft packing block

Vu a-POD - 10889981111472

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
21-40-0140
In Commercial Distribution

  • 10889981111472 ()
21-40-0140

  • Bone graft packing block

VuMesh - 10889981109103

Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
15-40-0300
In Commercial Distribution

  • 10889981109103 ()
15-40-0300

  • Bone graft packing block

Vu e-POD - 10889981109059

Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
14-40-0101
In Commercial Distribution

  • 10889981109059 ()
14-40-0101

  • Bone graft packing block

Vu cPOD - 10889981106874

Graft Packer Block
SEASPINE ORTHOPEDICS CORPORATION
11-40-0101
In Commercial Distribution

  • 10889981106874 ()
11-40-0101

  • Bone graft packing block

Coral - 10889981106638

Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
10-40-0330
In Commercial Distribution

  • 10889981106638 ()
10-40-0330

  • Bone graft packing block

Regatta Lateral System - 10889981162368

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
36-90-3061
In Commercial Distribution

  • 10889981162368 ()
36-90-3061

  • Bone graft packing block

Vu aPOD™ Prime NanoMetalene® - 10889981160067

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
33-40-0142
In Commercial Distribution

  • 10889981160067 ()
33-40-0142

  • Bone graft packing block

Specials - 10889981157609

VENTURA NM GRAFT PACKER
SEASPINE ORTHOPEDICS CORPORATION
SR-0229
In Commercial Distribution

  • 10889981157609 ()
SR-0229

  • 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

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

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

E-Pacer - 00858101008292

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

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual

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

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 - 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 - 10650551092879

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

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • 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 - 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 - 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 - 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 - 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

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

DEPTHALON® - 00650551101949

DEPTH ELECTRODE, PLATINUM, 2 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-02-MN-SS
In Commercial Distribution

  • 00650551101949 ()

  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 15 Millimeter
  • Contact Length 5 Millimeter
2102-02-MN-SS

  • Depth electrode

DEPTHALON® - 00650551098386

MICROWIRE DEPTH ELECTRODE, 8 MACRO CONTACTS, 24 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-08-24-001
In Commercial Distribution

  • 00650551098386 ()

  • Recording Depth 34.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 46 Centimeter
  • Contact Size 2 Millimeter
2104-08-24-001

  • Depth electrode

DEPTHALON® - 00650551098362

MICROWIRE DEPTH ELECTRODE, 5 MACRO CONTACTS, 20 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-05-20-02-IL
In Commercial Distribution

  • 00650551098362 ()

  • Recording Depth 19.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 16.5 Centimeter
  • Contact Size 1.5 Millimeter
2104-05-20-02-IL

  • Depth electrode

DEPTHALON® - 00650551098133

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-154
In Commercial Distribution

  • 00650551098133 ()

  • Main Tube Length 32 Centimeter
  • Spacing 2.4 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154

  • Depth electrode
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