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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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AXSOS - 07613252596202

Cortex Screw with Shaft
Stryker GmbH
661612
In Commercial Distribution

  • 07613252596202 ()

  • Length: 12.0 Millimeter
  • Diameter: 3.5 Millimeter
661612

  • Orthopaedic bone screw (non-sliding)

Neptune - 07613252497134

Suction Ring with Tubing
STRYKER CORPORATION
0702310000
In Commercial Distribution

  • 37613252497135 ()
  • 07613252497134 ()
0702310000

  • Suction/irrigation tubing, single-use

TiLock - M719GLC4630

Cannulated Drill with Shoulder
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GLC4630 ()
GLC463

  • Bone-screw internal spinal fixation system, non-sterile

TiLock - M719GL4170

Distractor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4170 ()
GL417

  • Bone-screw internal spinal fixation system, non-sterile

TiLock - M719GL4160

Compressor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4160 ()
GL416

  • Bone-screw internal spinal fixation system, non-sterile

mytaMed - B351735070

Freer Elevator with Suction
Mytamed, Inc.
7.35.07
Not in Commercial Distribution

  • B351735070 ()
7.35.07

  • Periosteal elevator, reusable

Valleylab - 10884524000824

Forceps with Stops,Semkin
Covidien LP
E4060-CT
In Commercial Distribution

  • 10884524000824 ()

  • Length: 14.0 Centimeter
  • tip,0.5,Millimeter;


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

full back conductive garment vest- med. - 00857771003521

with (8) 2x3 eletrodes
BIOMEDICAL LIFE SYSTEMS, INC.
KV1003823
In Commercial Distribution

  • 00857771003521 ()

  • Height: 1 Inch
  • Width: 12 Inch
  • Length: 12 Inch
KV1003823

  • Transcutaneous electrical stimulation electrode, single-use

WATCHMAN TruSteer™ Access System - 00191506022310

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU90050
In Commercial Distribution

  • 00191506022310 ()

  • Outer Diameter: 5.7 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
M635TU90050

  • Cardiac occluder delivery kit

NA - 10888551010788

BABCOCK GRASPER WITH RATCHET
STERILMED, INC.
ETH10BB
Not in Commercial Distribution

  • 10888551010788 ()
10BB

  • Flexible endoscopic tissue manipulation forceps, single-use

MEDLINE INDUSTRIES, INC. - 10198459390487

MINOR WITH LAP PACK
MEDLINE INDUSTRIES, INC.
DYNJ83855A
In Commercial Distribution

  • 40198459390488 ()
  • 10198459390487 ()
DYNJ83855A

  • General surgical procedure kit, non-medicated, single-use

Pilling - 00190776025168

Spurling Kerrison, with Ejector
Avalign Technologies, Inc.
P19181
In Commercial Distribution

  • 00190776025168 ()

  • Angle: 90 degree
  • Length: 6 Inch
  • Width: 3 Inch


  • Neurosurgical rongeur

Poly GIA - 10884521047679

Stapler with Polysorb Staples
Covidien LP
030775
Not in Commercial Distribution

  • 20884521047676 ()
  • 10884521047679 ()

  • Height: .060 Inch
  • Length: 75 Millimeter


  • Open-surgery manual linear cutting stapler, single-use

CARDINAL HEALTH - 10195594236885

SURGERY PACK WITH GOWN
Cardinal Health 200, LLC
SBA40SPAR2
In Commercial Distribution

  • 50195594236883 ()
  • 10195594236885 ()
SBA40SPAR2

  • General surgical procedure kit, non-medicated, single-use

FABCO - 30634303800480

Nasal Packing with string
FIRST AID BANDAGE CO INC
Q770404
In Commercial Distribution

  • 50634303800484 ()
  • 30634303800480 ()

  • Height: 1.5 Centimeter
  • Width: 2.0 Centimeter
  • Length: 8.0 Centimeter
Q770404

  • Intranasal splint, non-biodegradable

FABCO - 30634303800473

Nasal Packing with string
FIRST AID BANDAGE CO INC
Q770401
In Commercial Distribution

  • 50634303800477 ()
  • 30634303800473 ()

  • Height: 1.5 Centimeter
  • Width: 2.0 Centimeter
  • Length: 4.5 Centimeter
Q770401

  • Intranasal splint, non-biodegradable

ICU Medical - 00887709042360

Extension Set with Microclave
ICU MEDICAL, INC.
125510401
In Commercial Distribution

  • 10887709042367 ()
  • 00887709042360 ()
12551

  • Intravenous administration tubing extension set

Arthrex® - 00888867018556

SUTURE TENSIONER WITH TENSIOMETER
ARTHREX, INC.
AR-1529
In Commercial Distribution

  • 00888867018556 ()
AR-1529

  • Orthopaedic graft tensioner, reusable

Arthrex® - 00888867010086

SCREWDRIVER WITH AO CONNECTION
ARTHREX, INC.
AR-13223
In Commercial Distribution

  • 00888867010086 ()
AR-13223

  • Surgical screwdriver, reusable

Polar - 00885556776087

Polarstem Inserter with Groove
Smith & Nephew, Inc.
E0016846-2
In Commercial Distribution

  • 00885556776087 ()
E0016846-2

  • Orthopaedic inorganic implant inserter/extractor, reusable

Peri-loc - 00885556802830

HEXDRIVER WITH 2.5MM CANNULATION
Smith & Nephew, Inc.
E0017298-1
In Commercial Distribution

  • 00885556802830 ()
E0017298-1

  • Surgical screwdriver, reusable

Peri-loc - 00885556796061

HEXDRIVER WITH 2.5MM CANNULATION
Smith & Nephew, Inc.
E0017166-1
In Commercial Distribution

  • 00885556796061 ()
E0017166-1

  • Surgical screwdriver, reusable

JII - 00885556794944

BOX OSTEOTOME WITH BACKSLAP
Smith & Nephew, Inc.
E0017139-8
In Commercial Distribution

  • 00885556794944 ()
E0017139-8

  • Orthopaedic osteotome

Journey II - 00885556794777

BOX OSTEOTOME WITH BACKSLAP
Smith & Nephew, Inc.
E0017147-1
In Commercial Distribution

  • 00885556794777 ()
E0017147-1

  • Orthopaedic chisel

Prosthetic Accessories - 07290107273381

Plastic Sleeve with Hex
A.B. DENTAL DEVICES LTD
P7b-H
In Commercial Distribution

  • 27290107273385 ()
  • 17290107273388 ()
  • 07290107273381 ()
P7b-H

  • Dental implant suprastructure kit

Prosthetic Accessories - 07290107273244

Titanium Sleeve with Hex
A.B. DENTAL DEVICES LTD
P6H-bTH
In Commercial Distribution

  • 27290107273248 ()
  • 17290107273241 ()
  • 07290107273244 ()
P6H-bTH

  • Dental implant suprastructure kit

CARDINAL HEALTH - 10197106849675

CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CRE10
In Commercial Distribution

  • 50197106849673 ()
  • 10197106849675 ()
SNE69CRE10

  • Craniotomy kit

NA - 04546540066787

Kirschner Wire with Thread
Stryker GmbH
390175
In Commercial Distribution

  • 04546540066787 ()

  • Diameter: 2.0 Millimeter
  • Length: 150.0 Millimeter
390175

  • Orthopaedic bone pin, non-bioabsorbable

NA - 04546540066770

Kirschner Wire with Thread
Stryker GmbH
390170
In Commercial Distribution

  • 04546540066770 ()

  • Diameter: 1.4 Millimeter
  • Length: 150.0 Millimeter
390170

  • Orthopaedic bone pin, non-bioabsorbable

NA - 10705034788593

TI COLLAR WITH GROOVES
Synthes GmbH
498.011
In Commercial Distribution

  • H9814980110 ()
  • 10705034788593 ()
498011

  • Spinal bone set screw

WATCHMAN™ TruSeal™ Access System - 08714729965725

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU70040
Not in Commercial Distribution

  • 08714729965725 ()

  • Outer Diameter: 4.8 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
M635TU70040

  • Cardiac occluder delivery kit

WATCHMAN™ TruSeal™ Access System - 08714729965718

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU70020
Not in Commercial Distribution

  • 08714729965718 ()

  • Outer Diameter: 4.8 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
M635TU70020

  • Cardiac occluder delivery kit

WATCHMAN™ TruSeal™ Access System - 08714729965701

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU70010
Not in Commercial Distribution

  • 08714729965701 ()

  • Outer Diameter: 4.8 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
M635TU70010

  • Cardiac occluder delivery kit

PleuraFlow® System - 00856449006031

PF-32 PleuraFlow® System
Clearflow, Inc.
PF-32
Not in Commercial Distribution

  • 00856449006031 ()
  • 10856449006038 ()
  • 20856449006035 ()

  • Catheter Gauge: 32 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter

PleuraFlow® System - 00856449006024

PF-28 PleuraFlow® System
Clearflow, Inc.
PF-28
Not in Commercial Distribution

  • 10856449006021 ()
  • 00856449006024 ()
  • 20856449006028 ()

  • Catheter Gauge: 28 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial

PleuraFlow® System - 00856449006017

PF-24 PleuraFlow® System
Clearflow, Inc.
PF-24
Not in Commercial Distribution

  • 20856449006011 ()
  • 00856449006017 ()
  • 10856449006014 ()

  • Catheter Gauge: 24 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter

PleuraFlow® System - 00856449006000

PF-20 PleuraFlow® System
Clearflow, Inc.
PF-20
Not in Commercial Distribution

  • 00856449006000 ()
  • 10856449006007 ()
  • 20856449006004 ()

  • Catheter Gauge: 20 French


  • Pleural catheter
  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial

Guidewire Extension - 00816349011283

No Description
Lake Region Medical
LR1BN042V
In Commercial Distribution

  • 10816349011280 ()
  • 00816349011283 ()

  • Outer Diameter: 0.014 Inch
  • Length: 145 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

Triumph - 00816349011276

No Description
Lake Region Medical
LR1BN025V
In Commercial Distribution

  • 00816349011276 ()
  • 10816349011273 ()

  • Outer Diameter: 0.014 Inch
  • Length: 185 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

Triumph - 00816349011269

No Description
Lake Region Medical
LR1BN023V
In Commercial Distribution

  • 10816349011266 ()
  • 00816349011269 ()

  • Outer Diameter: 0.014 Inch
  • Length: 185 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

OSS™ Orthopedic Salvage System - 00880304240087

No Description
Biomet Orthopedics, LLC
150492
In Commercial Distribution

  • 00880304240087 ()

  • 15 mm 225 mm With Screw
150492

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304240070

No Description
Biomet Orthopedics, LLC
150491
In Commercial Distribution

  • 00880304240070 ()

  • 13 mm 225 mm With Screw
150491

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304240063

No Description
Biomet Orthopedics, LLC
150490
In Commercial Distribution

  • 00880304240063 ()

  • 11 mm 225 mm With Screw
150490

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304240056

No Description
Biomet Orthopedics, LLC
150489
In Commercial Distribution

  • 00880304240056 ()

  • 9 mm 225 mm With Screw
150489

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239722

No Description
Biomet Orthopedics, LLC
150451
In Commercial Distribution

  • 00880304239722 ()

  • 16.5 mm 150 mm With Screw
150451

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239715

No Description
Biomet Orthopedics, LLC
150450
In Commercial Distribution

  • 00880304239715 ()

  • 14.5 mm 150 mm With Screw
150450

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239708

No Description
Biomet Orthopedics, LLC
150449
In Commercial Distribution

  • 00880304239708 ()

  • 12.5 mm 150 mm With Screw
150449

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239692

No Description
Biomet Orthopedics, LLC
150448
In Commercial Distribution

  • 00880304239692 ()

  • 10.5 mm 150 mm With Screw
150448

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239685

No Description
Biomet Orthopedics, LLC
150447
In Commercial Distribution

  • 00880304239685 ()

  • 15 mm 150 mm With Screw
150447

  • Knee femur stem prosthesis

OSS™ Orthopedic Salvage System - 00880304239678

No Description
Biomet Orthopedics, LLC
150446
In Commercial Distribution

  • 00880304239678 ()

  • 13 mm 150 mm With Screw
150446

  • Knee femur stem prosthesis
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