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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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CONNECTOR, STRAIGHT 3/16" X 3/16" W/LUER - B066C115B1

A non-sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C115B
In Commercial Distribution

  • B066C115B1 ()
  • B066C115B5 ()
  • B066C115B4 ()
  • B066C115B3 ()
  • B066C115B2 ()
  • B066C115B0 ()
C115B

  • Luer/non-ISO80369-standardized linear connector, single-use

Gemini-C Cervical Interbody Device - B06220001003

TAMP, GEMINI-C
Osseus Fusion Systems, LLC
2000-1003
In Commercial Distribution

  • B06220001003 ()
2000-1003

  • Surgical tamp, reusable

CHATTANOOGA - 00888912374071

INTELECT IFC PORT PKG INT'L
DJO, LLC
77723
In Commercial Distribution

  • 00888912374071 ()


  • Interferential electrical stimulation system

CHATTANOOGA - 00888912374033

INTELECT IFC PORTABLE
DJO, LLC
77719
In Commercial Distribution

  • 00888912374033 ()


  • Interferential electrical stimulation system

Bio Protech - 00817120020579

MaxIF 1k Unit- Interferential Analog Unit
BIO PROTECH USA, INC.
MaxIF 1k Unit
In Commercial Distribution

  • 20817120020573 ()
  • 10817120020576 ()
  • 00817120020579 ()


  • Interferential electrical stimulation system

Bio Protech - 00817120020043

MaxIF 1k Unit- Interferential Analog Unit
BIO PROTECH USA, INC.
MaxIF 1k
In Commercial Distribution

  • 00817120020067 ()
  • 00817120020050 ()
  • 00817120020043 ()


  • Interferential electrical stimulation system

MediMax Tech - 00817325021661

Innostim IF 1000 Unit - Analog Inferential Unit
MEDIMAX TECH INC.
Innostim IF 1000 Unit
In Commercial Distribution

  • 20817325021665 ()
  • 10817325021668 ()
  • 00817325021661 ()


  • Interferential electrical stimulation system

C-Fuse® Cervical Intervertebral Body Fusion System - 00815351021808

Tamp Installation Tool
Southern Spine LLC
TA-690
In Commercial Distribution

  • 00815351021808 ()


  • Surgical tamp, reusable

AFT™ Proximal Humerus Fracture Plate System - 00815482020947

Fracture Reduction Forceps
Shoulder Options, Inc.
SO02-3085
In Commercial Distribution

  • 00815482020947 ()
SO02-3085

  • Orthopaedic bone-fragment manipulator, reusable

SAVI Dual(TM) Migraine Therapy - 00816140020132

Patient use, Non-invasive, Central Neuromodulation Smart Device
ENEURA, INC.,
DWG-0601
In Commercial Distribution

  • 00816140020132 ()


  • Home-use magnetic neural stimulator
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