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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

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

Stainless Steel - 10889981114800

Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0330
In Commercial Distribution

  • 10889981114800 ()
25-40-0330

  • 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

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

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

Mariner - 10889981128876

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

  • 10889981128876 ()
90-0530

  • 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

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

Reef TA - 10889981213022

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • 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

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

DEPTHALON® - 00650551131496

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
PMT CORPORATION
2102-16-154-NS
In Commercial Distribution

  • 00650551131496 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154-NS

  • Depth electrode

DEPTHALON® - 00650551131489

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 21MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-153-NS
In Commercial Distribution

  • 00650551131489 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153-NS

  • Depth electrode

DEPTHALON® - 00650551131472

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 13.98MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-152-NS
In Commercial Distribution

  • 00650551131472 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.43 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152-NS

  • Depth electrode

DEPTHALON® - 00650551131465

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 12MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-151-NS
In Commercial Distribution

  • 00650551131465 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151-NS

  • Depth electrode

DEPTHALON® - 00650551131458

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-143-NS
In Commercial Distribution

  • 00650551131458 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.8 Millimeter
  • Recording Depth 75 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-143-NS

  • Depth electrode

DEPTHALON® - 00650551131441

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-142-NS
In Commercial Distribution

  • 00650551131441 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-142-NS

  • Depth electrode

DEPTHALON® - 00650551131434

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-141-NS
In Commercial Distribution

  • 00650551131434 ()

  • Main Tube Length 27 Centimeter
  • Spacing 4.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-141-NS

  • Depth electrode

DEPTHALON® - 00650551131427

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-131-NS
In Commercial Distribution

  • 00650551131427 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 47.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-131-NS

  • Depth electrode

DEPTHALON® - 00650551131410

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-131-NS
In Commercial Distribution

  • 00650551131410 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 40.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-131-NS

  • Depth electrode

DEPTHALON® - 00650551131403

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-131-NS
In Commercial Distribution

  • 00650551131403 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-131-NS

  • Depth electrode

DEPTHALON® - 00650551131397

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-131-NS
In Commercial Distribution

  • 00650551131397 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-131-NS

  • Depth electrode

DEPTHALON® - 00650551131243

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-131-NS
In Commercial Distribution

  • 00650551131243 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 54.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-131-NS

  • Depth electrode

DEPTHALON® - 00650551130246

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-142
In Commercial Distribution

  • 00650551130246 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-142

  • Depth electrode

DEPTHALON® - 00650551130239

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-143
In Commercial Distribution

  • 00650551130239 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.8 Millimeter
  • Recording Depth 75 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-143

  • Depth electrode

DEPTHALON® - 00650551045809

DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2
In Commercial Distribution

  • 00650551045809 ()

  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 2 Millimeter
2102-08-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045793

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2
In Commercial Distribution

  • 00650551045793 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045786

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2
In Commercial Distribution

  • 00650551045786 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551041993

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108
In Commercial Distribution

  • 00650551041993 ()

  • Spacing 3.5 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 90 Millimeter
2102-16-108

  • Depth electrode
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