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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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Mariner - 10889981129200

Non-Ratcheting T-Handle, Cannulated, 1/4 in sq
Seaspine Orthopedics Corporation
90-0811
In Commercial Distribution

  • 10889981129200 ()

  • 1/4 in sq
90-0811

  • Surgical instrument handle, non-torque-limiting

Mariner - 10889981129187

Ratcheting Pineapple Handle, Cannulated, 1/4 in sq
Seaspine Orthopedics Corporation
90-0803
In Commercial Distribution

  • 10889981129187 ()

  • 1/4 in sq
90-0803

  • Surgical instrument handle, non-torque-limiting

Mariner - 10889981129163

Ratcheting Axial Handle, Cannulated , 1/4 in sq
Seaspine Orthopedics Corporation
90-0801
In Commercial Distribution

  • 10889981129163 ()

  • 1/4 in sq
90-0801

  • Surgical instrument handle, non-torque-limiting

Mariner - 10889981134556

Head Inserter, Locking, 1/4 in sq
Seaspine Orthopedics Corporation
90-0231
In Commercial Distribution

  • 10889981134556 ()

  • 1/4 in sq
90-0231

  • Orthopaedic inorganic implant inserter/extractor, reusable

Mariner - 10889981129217

Non-Ratcheting Pineapple Handle, Cannulated, 1/4 in sq
Seaspine Orthopedics Corporation
90-0812
In Commercial Distribution

  • 10889981129217 ()

  • 1/4 in sq
90-0812

  • Surgical instrument handle, non-torque-limiting

Mariner - 10889981129194

Non-Ratcheting Axial Handle, Cannulated , 1/4 in sq
Seaspine Orthopedics Corporation
90-0810
In Commercial Distribution

  • 10889981129194 ()

  • 1/4 in sq
90-0810

  • Surgical instrument handle, non-torque-limiting

Mariner - 10889981129170

Ratcheting T-Handle, Cannulated, 1/4 in sq
Seaspine Orthopedics Corporation
90-0802
In Commercial Distribution

  • 10889981129170 ()

  • 1/4 in sq
90-0802

  • Surgical instrument handle, non-torque-limiting

SeaSpine® Spacer System - Redondo - 10889981091507

Rasp, 15 in x 18mm
Seaspine Orthopedics Corporation
93-6158
In Commercial Distribution

  • 10889981091507 ()

  • 15 in x 18mm
93-6158

  • Bone file/rasp, manual, reusable

SeaSpine® Spacer System - Redondo - 10889981091484

Rasp, 15 in x 16mm
Seaspine Orthopedics Corporation
93-6156
In Commercial Distribution

  • 10889981091484 ()

  • 15 in x 16mm
93-6156

  • Bone file/rasp, manual, reusable

SeaSpine® Spacer System - Redondo - 10889981091460

Rasp, 15 in x 14mm
Seaspine Orthopedics Corporation
93-6154
In Commercial Distribution

  • 10889981091460 ()

  • 15 in x 14mm
93-6154

  • Bone file/rasp, manual, reusable

SeaSpine® Spacer System - Redondo - 10889981091446

Rasp, 15 in x 12mm
Seaspine Orthopedics Corporation
93-6152
In Commercial Distribution

  • 10889981091446 ()

  • 15 in x 12mm
93-6152

  • Bone file/rasp, manual, reusable

SeaSpine® Spacer System - Redondo - 10889981091422

Rasp, 15 in x 10mm
Seaspine Orthopedics Corporation
93-6150
In Commercial Distribution

  • 10889981091422 ()

  • 15 in x 10mm
93-6150

  • Bone file/rasp, manual, reusable

Cambria - 10889981093167

Rasp, 8.5 in, 12 mm
Seaspine Orthopedics Corporation
93-9322
In Commercial Distribution

  • 10889981093167 ()

  • 8.5 in, 12 mm
93-9322

  • Bone file/rasp, manual, reusable

Cambria - 10889981093150

Rasp, 8.5 in, 11 mm
Seaspine Orthopedics Corporation
93-9321
In Commercial Distribution

  • 10889981093150 ()

  • 8.5 in, 11 mm
93-9321

  • Bone file/rasp, manual, reusable

Cambria - 10889981093143

Rasp, 8.5 in, 10 mm
Seaspine Orthopedics Corporation
93-9320
In Commercial Distribution

  • 10889981093143 ()

  • 8.5 in, 10 mm
93-9320

  • Bone file/rasp, manual, reusable

Cambria - 10889981093136

Rasp, 8.5 in, 9 mm
Seaspine Orthopedics Corporation
93-9319
In Commercial Distribution

  • 10889981093136 ()

  • 8.5 in, 9 mm
93-9319

  • Bone file/rasp, manual, reusable

Cambria - 10889981093129

Rasp, 8.5 in, 8 mm
Seaspine Orthopedics Corporation
93-9318
In Commercial Distribution

  • 10889981093129 ()

  • 8.5 in, 8 mm
93-9318

  • Bone file/rasp, manual, reusable

Cambria - 10889981093112

Rasp, 8.5 in, 7 mm
Seaspine Orthopedics Corporation
93-9317
In Commercial Distribution

  • 10889981093112 ()

  • 8.5 in, 7 mm
93-9317

  • Bone file/rasp, manual, reusable

Cambria - 10889981093105

Rasp, 8.5 in, 6 mm
Seaspine Orthopedics Corporation
93-9316
In Commercial Distribution

  • 10889981093105 ()

  • 8.5 in, 6 mm
93-9316

  • Bone file/rasp, manual, reusable

Cambria - 10889981093099

Rasp, 8.5 in, 5 mm
Seaspine Orthopedics Corporation
93-9315
In Commercial Distribution

  • 10889981093099 ()

  • 8.5 in, 5 mm
93-9315

  • Bone file/rasp, manual, reusable

MOORE HOLLOW CHISEL - 00880304376984

No Description
Biomet Orthopedics, LLC
437920
In Commercial Distribution

  • 00880304376984 ()

  • LENGTH: 8 IN.(203MM)
437920

  • Orthopaedic chisel blade

TruWave, VAMP Plus - 00690103200003

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPL0097
In Commercial Distribution

  • 50690103200008 ()
  • 00690103200003 ()

  • 85 in (216 cm)
PXVPL0097

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use

TruLink - 10841522129797

LDWR SET,PINCH,ECG 127CM/50IN,5LW/SET,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
In Commercial Distribution

  • 00841522129790 ()
  • 10841522129797 ()

  • 127 cm/ 50 in
700-0006-32

  • Electrocardiographic lead set, reusable

TITAN™ - 10381780258322

Angled Handle
Ascension Orthopedics, Inc.
HDL-0926-001
In Commercial Distribution

  • M269HDL09260011 ()
  • 10381780258322 ()

  • 3.4 in L rod


  • Orthopaedic implant-instrument extension adaptor, reusable

Integra® - 10381780248026

Integra® External Fixation System The AO t-handle is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
5010001000
In Commercial Distribution

  • M26950100010001 ()
  • 10381780248026 ()

  • 4.399 in L handle
5010001000

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780247425

Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral body.
Ascension Orthopedics, Inc.
SP0920068001
In Commercial Distribution

  • M269SEP09200680011 ()
  • 10381780247425 ()

  • 9.33 in L caliper
SEP-0920-068-001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Construct ™ - 10381780246572

Construct® Ankle Fusion Plate System The depth gauge for plate screws is a tool used to measure the required depth of a drilled hole.
Ascension Orthopedics, Inc.
PDG-5010-01
Not in Commercial Distribution

  • M269PDG5010011 ()
  • 10381780246572 ()

  • .044 in W tip
PDG501001

  • Surgical depth gauge, reusable

Integra® - 10381780245735

Modular Radial Head Impactor, Stem, MRH
Ascension Orthopedics, Inc.
IMP35000
In Commercial Distribution

  • M269IMP350001 ()
  • 10381780245735 ()

  • .375 in inner dia
IMP-350-00

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245438

Titan™ Reverse Shoulder System The glenoid wire guide is used to determine proper guide pin positioning.
Ascension Orthopedics, Inc.
GWG096005301
In Commercial Distribution

  • M269GWG0960053011 ()
  • 10381780245438 ()

  • 7.0 in L handle
GWG-0960-053-01

  • Orthopaedic guidewire, reusable

Titan™ - 10381780245421

Titan™ Reverse Shoulder System The glenoid wire guide is eccentric with a lip and is used to determine proper guide pin positioning.
Ascension Orthopedics, Inc.
GWG0960050EL
In Commercial Distribution

  • M269GWG0960050EL1 ()
  • 10381780245421 ()

  • 7.0 in L handle
GWG-0960-050-EL

  • Orthopaedic guidewire, reusable
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