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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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Integra® External Fixation System - 10381780125280

The hex post is used to connect and support rings in the construct. The hex post is made from stainless steel.
Ascension Orthopedics, Inc.
12224210
In Commercial Distribution

  • 10381780125280 ()

  • 20 mm L
12224210

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125273

The angular half pin fixation clamp is made from stainless steel and is used to connect half pins to the rings.
Ascension Orthopedics, Inc.
12225010
In Commercial Distribution

  • 10381780125273 ()

  • .97 in L x .846 in W; .394 in taper
12225010

  • External orthopaedic fixation system, reusable

NeoBar® - 00812594011849

The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Assorted
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011849 ()
N719N

  • Endotracheal tube holder

NeoBar® - 00812594011832

The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Neobar Transport Box
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011832 ()
N718

  • Endotracheal tube holder

Syringe, 10 mL - 10628678061061

The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.
Front Line Medical Technologies Inc.
E01P3
In Commercial Distribution

  • 10628678061061 ()

  • Total Volume: 10 Milliliter
E01P3

  • General-purpose syringe, single-use

Torrent - 00816765014639

The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program.
US Endoscopy
00711579
Not in Commercial Distribution

  • 00816765014639 ()
00711579

  • Surgical irrigation pump

Cadence™ - 10381780356301

Cadence Tibial Impactor Handle is attached to the Tibial Impactor Tip which is used in the insertion of the Tibial Tray.
Ascension Orthopedics, Inc.
10203137
In Commercial Distribution

  • 10381780356301 ()

  • 5.16in Lx .425in diameter
10203137

  • Joint prosthesis implantation kit, reusable

Integra® Proximal Humeral Fracture Plate System - 10381780121251

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3575LS
In Commercial Distribution

  • 10381780121251 ()
  • M269PSS3575LS1 ()

  • 3.061 in L x .138 in dia
PSS3575LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable

Integra® Proximal Humeral Fracture Plate System - 10381780121244

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3570LS
In Commercial Distribution

  • M269PSS3570LS1 ()
  • 10381780121244 ()

  • 2.864 in L x .138 in dia
PSS3570LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Integra® Proximal Humeral Fracture Plate System - 10381780121237

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3565LS
In Commercial Distribution

  • M269PSS3565LS1 ()
  • 10381780121237 ()

  • 2.667 in L x .138 in dia
PSS3565LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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