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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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Zuma - 10889981096533

Graft Packing Block, 32mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
95-5192
In Commercial Distribution

  • 10889981096533 ()

  • 32mm x 25mm
95-5192

  • Bone graft packing block

Zuma - 10889981096526

Graft Packing Block, 26mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
95-5191
In Commercial Distribution

  • 10889981096526 ()

  • 26mm x 24mm
95-5191

  • 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

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

Cambria NanoMetalene - 10889981093839

Cambria NM Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-9834
In Commercial Distribution

  • 10889981093839 ()
93-9834

  • Bone graft packing block

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

Specials - 10889981285364

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

  • 10889981285364 ()
SR-0755

  • Bone graft packing block

Reef TO - 10889981195755

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • 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

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 - 00650551025412

sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode

DEPTHALON - 00650551005506

SEEG, 16 CONTACT, 2MM & 0.5MM CONTACT DIA., 5MM SPACING AND 13MM BETWEEN CONTACT 9&10, 33MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-174
In Commercial Distribution

  • 00650551005506 ()


  • Depth electrode

DEPTHALON - 00650551002659

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-185-NS
In Commercial Distribution

  • 00650551002659 ()


  • Depth electrode

DEPTHALON - 00650551002642

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-184-NS
In Commercial Distribution

  • 00650551002642 ()


  • Depth electrode

DEPTHALON - 00650551002048

PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH Copy
PMT CORPORATION
2102-16-185
In Commercial Distribution

  • 00650551002048 ()


  • Depth electrode

DEPTHALON - 00650551002031

PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 29MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-16-184
In Commercial Distribution

  • 00650551002031 ()


  • Depth electrode

DEPTHALON - 00650551001881

PLATINUM, 4 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 12.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-04-131
In Commercial Distribution

  • 00650551001881 ()


  • Depth electrode

DEPTHALON - 00650551001799

MICROWIRE DEPTHALON ELECTRODE, 7 X 2MM MACRO CONTACTS, 9 X 75UM MICROWIRE CONTACTS, 30MM RECORDING LENGTH, 0.8MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-09-001
In Commercial Distribution

  • 00650551001799 ()


  • Depth electrode

DEPTHALON - 00650551001430

SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACNG AND 37MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 57MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-183
In Commercial Distribution

  • 00650551001430 ()


  • Depth electrode

DEPTHALON - 00650551001423

SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 53MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-182
In Commercial Distribution

  • 00650551001423 ()


  • Depth electrode

DEPTHALON - 00650551001416

SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 29MM BETWEEN CONTACT 9&10 WITH 7-2MM BLANK CONTACTS, 49MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-181
In Commercial Distribution

  • 00650551001416 ()


  • Depth electrode

DEPTHALON - 00650551001409

SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 25MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 45MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-180
In Commercial Distribution

  • 00650551001409 ()


  • Depth electrode

DEPTHALON - 00650551001393

SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 8-2MM BLANK CONTACTS, 66MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-179
In Commercial Distribution

  • 00650551001393 ()


  • Depth electrode

DEPTHALON - 00650551001386

SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-178
In Commercial Distribution

  • 00650551001386 ()


  • Depth electrode

DEPTHALON - 00650551001201

SEEG, 14 CONTACT, 2MM CONTACT SIZE, 5.33MM CTC SPACING, 71.3MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-14-147
In Commercial Distribution

  • 00650551001201 ()


  • Depth electrode

DEPTHALON - 00650551001171

SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6.53MM CTC SPACING, 100MM RECORDING DEPTH, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-156
In Commercial Distribution

  • 00650551001171 ()


  • Depth electrode

DEPTHALON - 00650551001140

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode

DEPTHALON - 00650551000860

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode
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