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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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OverStitch Endoscopic Suturing System - 10811955020664

Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-G02-160
In Commercial Distribution

  • 10811955020664 ()
  • 20811955020661 ()
ESS-G02-160

  • Suturing unit, single-use

Innomed, Inc. - 00840277121608

Eickmann Revision Chisel 20" Exchange
INNOMED, INC.
5470-20-E
In Commercial Distribution

  • 00840277121608 ()
5470-20-E

  • Orthopaedic osteotome

Innomed, Inc. - 00840277121585

Eickmann Revision Chisel 8mm Exchange
INNOMED, INC.
5470-08-E
In Commercial Distribution

  • 00840277121585 ()
5470-08-E

  • Orthopaedic osteotome

Xper Flex Cardio Physiomonitoring System - 00884838093775

Xper FC2010 Rev E EXCHANGE
Philips Ds North America LLC
Xper FC2010 Rev E EXCHANGE
In Commercial Distribution

  • 00884838093775 ()
453564845841

  • General-purpose multi-parameter bedside monitor

Xper Flex Cardio Physiomonitoring System - 00884838091474

Xper FC2010 Rev D EXCHANGE
Philips Ds North America LLC
Xper FC2010 Rev D EXCHANGE
In Commercial Distribution

  • 00884838091474 ()
453564669081

  • General-purpose multi-parameter bedside monitor

PediNail - 00841132135273

GUIDE WIRE/EXCHANGE TUBE BOX
ORTHOPEDIATRICS CORP.
11-1500-0234
In Commercial Distribution

  • 00841132135273 ()
11-1500-0234

  • Instrument tray, reusable

Stamey - 00827002143135

Stamey Suprapubic Catheter Exchange Set
COOK INCORPORATED
G14313
In Commercial Distribution

  • 00827002143135 ()
081212

  • Suprapubic drainage catheter

Stamey - 00827002142732

Stamey Suprapubic Catheter Exchange Set
COOK INCORPORATED
G14273
In Commercial Distribution

  • 00827002142732 ()
081214

  • Suprapubic drainage catheter

McNamara - 00827002116139

McNamara Renal Exchange Wire Guide
COOK INCORPORATED
G11613
In Commercial Distribution

  • 00827002116139 ()
TPCMG-18SP-260-MR120

  • Peripheral vascular guidewire, manual

McNamara - 00827002116153

McNamara Renal Exchange Wire Guide
COOK INCORPORATED
G11615
In Commercial Distribution

  • 00827002116153 ()
TPCMG-18SP-260-MR90

  • Peripheral vascular guidewire, manual
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