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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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RISE Splint - 00818630015536

The RISE™ (Rigid Immobilization System for Extremities) is a rugged, low-profile, splint for extremity fractures and pelvic binding in the prehospital environment. Born from lessons on the battlefield, it can be intuitively applied under stress to create a straight splint, 90-degree splint, or pelvic binder. It can be easily secured to the patient with items such as an elastic wrap or pressure bandage. It features dynamic living hinges that allow the splint to collapse for maximum portability and kit space savings while easily form-fitting to the required shape and dimensions for proper upper and lower extremity splinting of fractures. With its compact size, the RISE™ fits into most individual first aid kits including all standard military-issued IFAKs. Unique to the RISE™, multiple cutout slots provide you the capability to create a pelvic binder when paired with a windlass or ratcheting tourniquet such as our new SOF® Tourniquet. The Committee on Tactical Combat Casualty Care (CoTCCC) recognizes splinting and pelvic binding application as a critical step to prevent additional injury before moving a casualty. The one-of-a-kind design is made of a lightweight polymer capable of withstanding surface cleaning and harsh elements, including saltwater while maintaining its rigidity and durability. Whether you’re on the battlefield or a responder here at home, the RISE™ is an advantageous addition to any IFAK for increasing your medical capability at the point of injury when needed most.
TACTICAL MEDICAL SOLUTIONS, LLC
1
In Commercial Distribution

  • 00818630015536 ()
  • 00818630015598 ()
  • 00818630015604 ()
87-1046

  • First aid limb splint, mouldable, reusable

Guardian Splint - 08809818038135

This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
BM KOREA CO., LTD
GSL-S
In Commercial Distribution

  • 08809818038135 ()

  • Length: 300 Millimeter
  • Width: 100 Millimeter


  • First aid limb splint, non-mouldable, reusable

Merlin™ - 05414734503143

RF Telemetry Antenna Adapter
ST. JUDE MEDICAL, INC.
EX3190
In Commercial Distribution

  • 05414734503143 ()

  • Length: 7.9 Inch
EX3190

  • External pacemaker analyser

Merlin™ - 05414734503136

Adapter Medtronic Patient Cable Model 2292
ST. JUDE MEDICAL, INC.
EX3180
In Commercial Distribution

  • 05414734503136 ()

  • Length: 10 Inch
EX3180

  • External pacemaker analyser

Merlin™ - 05414734503129

Adapter for Single-Use Patient Cable
ST. JUDE MEDICAL, INC.
EX3170
In Commercial Distribution

  • 05414734503129 ()

  • Length: 10 Inch
EX3170

  • External pacemaker analyser

Merlin™ - 05414734503105

Pacing System Analyzer
ST. JUDE MEDICAL, INC.
EX3100
In Commercial Distribution

  • 05414734503105 ()
EX3100

  • External pacemaker analyser

Portex - 00351688000180

No Description
ICU MEDICAL, INC.
A1709
In Commercial Distribution

  • 10351688000187 ()
  • 00351688000180 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688069262

No Description
ICU MEDICAL, INC.
4910NM-18
In Commercial Distribution

  • 10351688069269 ()
  • 00351688069262 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688069255

No Description
ICU MEDICAL, INC.
4910N-18
In Commercial Distribution

  • 10351688069252 ()
  • 00351688069255 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688069231

No Description
ICU MEDICAL, INC.
4910NM-16/17
In Commercial Distribution

  • 10351688069238 ()
  • 00351688069231 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688047574

No Description
ICU MEDICAL, INC.
4917M-19
In Commercial Distribution

  • 10351688047571 ()
  • 00351688047574 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688037445

No Description
ICU MEDICAL, INC.
4919-18
In Commercial Distribution

  • 10351688037442 ()
  • 00351688037445 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688036561

No Description
ICU MEDICAL, INC.
4912-18
In Commercial Distribution

  • 10351688036568 ()
  • 00351688036561 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688032259

No Description
ICU MEDICAL, INC.
4910-16/17
In Commercial Distribution

  • 10351688032256 ()
  • 00351688032259 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688028764

No Description
ICU MEDICAL, INC.
4916-16/17
In Commercial Distribution

  • 10351688028761 ()
  • 00351688028764 ()


  • General-purpose catheter connector, non-sterile

Portex - 00351688020782

No Description
ICU MEDICAL, INC.
4918-16/17
In Commercial Distribution

  • 10351688020789 ()
  • 00351688020782 ()


  • General-purpose catheter connector, non-sterile

Portex - 20351688074901

No Description
ICU MEDICAL, INC.
A3678
Not in Commercial Distribution

  • 30351688074908 ()
  • 20351688074901 ()


  • General-purpose catheter connector, non-sterile

N/A - 06009544050568

V2-GC-90772
SOUTHERN IMPLANTS (PTY) LTD
V2-GC-90772
In Commercial Distribution

  • 06009544050568 ()


  • External facial prosthesis attachment frame component

Sigma - 00190376471426

Blade Depth Gauge
ALPHATEC SPINE, INC.
350-060
In Commercial Distribution

  • 00190376471426 ()


  • Medical ruler, reusable

TruWave - 00690103216806

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPZ10025
In Commercial Distribution

  • 50690103216801 ()
  • 00690103216806 ()

  • TOTAL VOLUME: 30 MILLILITER, LENGTH: 18 INCH (46.5 CENTIMETER)
PXVPZ10025

  • Invasive-pressure external transducer, single-use

TRUWAVE - 00690103197730

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK0036
In Commercial Distribution

  • 00690103197730 ()
  • 50690103197735 ()

  • Total Volume: 3 Milliliter
PXMK0036

  • Invasive-pressure external transducer, single-use

TRUWAVE - 00690103149678

PRESSURE MONITORING KIT
Edwards Lifesciences LLC
PXMK1326
In Commercial Distribution

  • 50690103149673 ()
  • 00690103149678 ()

  • Total Volume: 3 Milliliter, Length: 11 Inch (28 Centimeter)
PXMK1326

  • Invasive-pressure external transducer, single-use

TRUWAVE - 00690103148329

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK1350
In Commercial Distribution

  • 50690103148324 ()
  • 00690103148329 ()

  • Total Volume: 3 Milliliter, Length: 82 Inch (208 Centimeter)
PXMK1350

  • Invasive-pressure external transducer, single-use

TRUWAVE - 00690103014747

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK318
In Commercial Distribution

  • 00690103014747 ()
  • 50690103014742 ()

  • Total Volume: 3 Milliliter
PXMK318

  • Invasive-pressure external transducer, single-use

TruWave - 00690103011548

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXCMK315
In Commercial Distribution

  • 50690103011543 ()
  • 00690103011548 ()

  • Total Volume: 3 Milliliter, Length: 56 Inch (142 Centimeter)
PXCMK315

  • Invasive-pressure external transducer, single-use

Millennium - 00190776306519

Wurapa Pin Distractor 1.1mm 1.6mm dia
Avalign Technologies, Inc.
1-1752
In Commercial Distribution

  • 00190776306519 ()


  • Orthopaedic surgical distractor, external

Millennium - 00190776304652

Large Pin Distractor Hole Diameter 3.2mm
Avalign Technologies, Inc.
1-4233
In Commercial Distribution

  • 00190776304652 ()


  • Orthopaedic surgical distractor, external

Millennium - 00190776187200

CALCANEAL DISTRACTOR SMALL STRAIGHT WITH THUMBSCREW
Avalign Technologies, Inc.
1-4215SS
In Commercial Distribution

  • 00190776187200 ()


  • Orthopaedic surgical distractor, external

NA - 00841379192077

LLIF DISTRACTOR
HYHTE HOLDINGS, INC.
GZC030018
In Commercial Distribution

  • 00841379192077 ()

  • Width: 18 Millimeter
GZC030018

  • Orthopaedic surgical distractor, external

NA - 00841379192060

LLIF DISTRACTOR
HYHTE HOLDINGS, INC.
GZC030017
In Commercial Distribution

  • 00841379192060 ()

  • Width: 17 Millimeter
GZC030017

  • Orthopaedic surgical distractor, external
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