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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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SAPPHIRE X - 00840606151320

SAPPHIRE X® FIXED DRILL GUIDE 30°
SPINAL ELEMENTS, INC.
27022-030
In Commercial Distribution

  • 00840606151320 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606151313

SAPPHIRE X® FIXED DRILL GUIDE 15°
SPINAL ELEMENTS, INC.
27022-015
In Commercial Distribution

  • 00840606151313 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160438

SAPPHIRE X, AWL-DRILL SLEEVE CAP
SPINAL ELEMENTS, INC.
27031-001
Not in Commercial Distribution

  • 00840606160438 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160421

SAPPHIRE X®, AWL-DRILL VARIABLE GUIDE
SPINAL ELEMENTS, INC.
27031-000
In Commercial Distribution

  • 00840606160421 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160414

SAPPHIRE X®, 10MM AWL
SPINAL ELEMENTS, INC.
27034-000
In Commercial Distribution

  • 00840606160414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160407

SAPPHIRE X®, AWL-DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27033-018
In Commercial Distribution

  • 00840606160407 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160391

SAPPHIRE X®, AWL-DRILL Ø2.0 X 16MM
SPINAL ELEMENTS, INC.
27033-016
In Commercial Distribution

  • 00840606160391 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160384

SAPPHIRE X®, AWL-DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27033-014
In Commercial Distribution

  • 00840606160384 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160377

SAPPHIRE X®, AWL-DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27033-012
In Commercial Distribution

  • 00840606160377 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160360

SAPPHIRE X®, AWL-DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27033-010
In Commercial Distribution

  • 00840606160360 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160353

SAPPHIRE X®, DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27032-018
In Commercial Distribution

  • 00840606160353 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160346

SAPPHIRE X®, DRILL Ø2.0 X 16MM
SPINAL ELEMENTS, INC.
27032-016
In Commercial Distribution

  • 00840606160346 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160339

SAPPHIRE X®, DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27032-014
In Commercial Distribution

  • 00840606160339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160322

SAPPHIRE X®, DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27032-012
In Commercial Distribution

  • 00840606160322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160315

SAPPHIRE X®, DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27032-010
In Commercial Distribution

  • 00840606160315 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606159982

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 18MM
SPINAL ELEMENTS, INC.
27001-018
In Commercial Distribution

  • 00840606159982 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159975

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 16MM
SPINAL ELEMENTS, INC.
27001-016
In Commercial Distribution

  • 00840606159975 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159968

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 14MM
SPINAL ELEMENTS, INC.
27001-014
In Commercial Distribution

  • 00840606159968 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159951

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 13MM
SPINAL ELEMENTS, INC.
27001-013
In Commercial Distribution

  • 00840606159951 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159944

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 12MM
SPINAL ELEMENTS, INC.
27001-012
In Commercial Distribution

  • 00840606159944 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159937

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 11MM
SPINAL ELEMENTS, INC.
27001-011
In Commercial Distribution

  • 00840606159937 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159920

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 10MM
SPINAL ELEMENTS, INC.
27001-010
In Commercial Distribution

  • 00840606159920 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159913

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 9MM
SPINAL ELEMENTS, INC.
27001-009
In Commercial Distribution

  • 00840606159913 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159906

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 8MM
SPINAL ELEMENTS, INC.
27001-008
In Commercial Distribution

  • 00840606159906 ()


  • Spinal fixation plate, non-bioabsorbable

Oligio X - 08800022305327

Radio Frequency Therapy System
WONTECH CO.,LTD
Oligio X
In Commercial Distribution

  • 08800022305327 ()


  • Radio-frequency skin/body contouring system

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

Multicare X - 08592654470589

Electrically operated hospital bed.
L I N E T spol. s r.o.
1MCX12050-906
In Commercial Distribution

  • 08592654470589 ()


  • Basic electric hospital bed

OptiCare X - 08592654394229

active integrated anti-decubitus mattresses
L I N E T spol. s r.o.
1VSR000211100
In Commercial Distribution

  • 08592654394229 ()


  • Alternating-pressure bed mattress overlay system

OptiCare X - 08592654363188

active integrated anti-decubitus mattresses
L I N E T spol. s r.o.
1VSM000211100
In Commercial Distribution

  • 08592654363188 ()


  • Alternating-pressure bed mattress overlay system

Multicare X - 08592654339688

Electrically operated hospital bed.
L I N E T spol. s r.o.
1MCX12050-101
In Commercial Distribution

  • 08592654339688 ()


  • Basic electric hospital bed

BioWick X - M543CM6265

BioWick X 6.5mm Pre-Loaded Implant
CAYENNE MEDICAL, INC.
CM-6265
In Commercial Distribution

  • M543CM6265 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

BioWick X - M543CM6255

BioWick X 5.5mm Pre-Loaded Implant
CAYENNE MEDICAL, INC.
CM-6255
In Commercial Distribution

  • M543CM6255 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

OptiCross X - 08714729893264

Coronary Imaging Catheter
BOSTON SCIENTIFIC CORPORATION
H74939405030
Not in Commercial Distribution

  • 08714729893264 ()

  • 3.0 F Diameter
  • 135 cm Effective Length
  • 1.00 mm Diameter


  • Intravascular ultrasound imaging catheter, single-use

SAPPHIRE X - 00840606175616

SAPPHIRE X® INSERTER STOP SLEEVE LONG
SPINAL ELEMENTS, INC.
27011-003
In Commercial Distribution

  • 00840606175616 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606175609

SAPPHIRE X® INSERTER STOP SLEEVE MEDIUM
SPINAL ELEMENTS, INC.
27011-002
In Commercial Distribution

  • 00840606175609 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606175593

SAPPHIRE X® INSERTER STOP SLEEVE SHORT
SPINAL ELEMENTS, INC.
27011-001
In Commercial Distribution

  • 00840606175593 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606169752

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 110MM
SPINAL ELEMENTS, INC.
27005-110
In Commercial Distribution

  • 00840606169752 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169707

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 105MM
SPINAL ELEMENTS, INC.
27005-105
In Commercial Distribution

  • 00840606169707 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169653

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 100MM
SPINAL ELEMENTS, INC.
27005-100
In Commercial Distribution

  • 00840606169653 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169608

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 95MM
SPINAL ELEMENTS, INC.
27005-095
In Commercial Distribution

  • 00840606169608 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169554

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 90MM
SPINAL ELEMENTS, INC.
27005-090
In Commercial Distribution

  • 00840606169554 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169509

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 85MM
SPINAL ELEMENTS, INC.
27005-085
In Commercial Distribution

  • 00840606169509 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169455

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 80MM
SPINAL ELEMENTS, INC.
27005-080
In Commercial Distribution

  • 00840606169455 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169400

5-LEVEL SAPPHIRE X® CERVICAL PLATE, 75MM
SPINAL ELEMENTS, INC.
27005-075
In Commercial Distribution

  • 00840606169400 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169288

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 84MM
SPINAL ELEMENTS, INC.
27004-084
In Commercial Distribution

  • 00840606169288 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169240

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 80MM
SPINAL ELEMENTS, INC.
27004-080
In Commercial Distribution

  • 00840606169240 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169202

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 76MM
SPINAL ELEMENTS, INC.
27004-076
In Commercial Distribution

  • 00840606169202 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169165

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 72MM
SPINAL ELEMENTS, INC.
27004-072
In Commercial Distribution

  • 00840606169165 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169127

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 68MM
SPINAL ELEMENTS, INC.
27004-068
In Commercial Distribution

  • 00840606169127 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606169080

4-LEVEL SAPPHIRE X® CERVICAL PLATE, 64MM
SPINAL ELEMENTS, INC.
27004-064
In Commercial Distribution

  • 00840606169080 ()


  • Spinal fixation plate, non-bioabsorbable
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