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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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ReShape Lap-Band® 2.0, FLEX & Access Port, Large
ReShape Lifesciences Inc.
D-3306
In Commercial Distribution

  • 00850007764555 ()

  • Large
D-3306

  • Gastric band access port kit
ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
ReShape Lifesciences Inc.
D-3304
In Commercial Distribution

  • 00850007764548 ()

  • Standard
D-3304

  • Gastric band access port kit
RapidPort® EZ Access Port Kit (0-14cc) for use with LAP-BAND® AP System Large
ReShape Lifesciences Inc.
C-2306
In Commercial Distribution


  • 0-14cc
C-2306

  • Gastric band access port kit
RapidPort®EZ Access Port Kit (0-10cc) for use with LAP-BAND® AP System Standard
ReShape Lifesciences Inc.
C-2304
In Commercial Distribution


  • 0-10cc
C-2304

  • Gastric band access port kit
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0018
Not in Commercial Distribution

  • 00859932006143 ()


  • General/multiple surgical solid-state laser system
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device. As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is provided in the kit for use as a primary dressing for the surgical incision as well as a slip-tip syringe.
New Wave Endo-Surgery Inc.
27-108
In Commercial Distribution

  • 00850009417220 ()
  • 00850009417213 ()
  • 00850009417237 ()
  • 00850009417244 ()

  • Outer Diameter: 12 Millimeter
27-108

  • Suturing unit, single-use
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.
New Wave Endo-Surgery Inc.
27-101
In Commercial Distribution

  • 00850009417053 ()
  • 00850009417022 ()
  • 00850009417060 ()
  • 00850009417107 ()

  • Outer Diameter: 12 Millimeter
27-101

  • Suturing unit, single-use
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0021
Not in Commercial Distribution

  • 00859932006099 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0087
Not in Commercial Distribution

  • 00859932006075 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0023
Not in Commercial Distribution

  • 00859932006068 ()


  • General/multiple surgical solid-state laser system
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