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 Type Device Class Implantable

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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
RapidPort® EZ Port Applier Tool
Reshape Lifesciences Inc.
C-20390
In Commercial Distribution

C-20390

  • Infusion/injection port/tack applicator
LAP-BAND® AP Adjustable Gastric Banding System Large with RapidPort EZ
Reshape Lifesciences Inc.
C-2365
In Commercial Distribution


  • Large
C-2365

  • Gastric band
LAP-BAND® AP Adjustable Gastric Banding System Standard with RapidPort EZ
Reshape Lifesciences Inc.
C-2360
In Commercial Distribution


  • Standard
C-2360

  • Gastric band
LAP-BAND® Access Port Needle 2 inch Pouch
Reshape Lifesciences Inc.
B-20302-10
In Commercial Distribution

  • 10850007764323 ()
  • 10811955020428 ()
  • 00850007764326 ()
B-20302-10

  • Subcutaneous infusion/injection port needle
LAP-BAND® Access Port Needle 3.5 inch Pouch
Reshape Lifesciences Inc.
B-20301-10
In Commercial Distribution

  • 10850007764330 ()
  • 10811955020411 ()
  • 00850007764333 ()
B-20301-10

  • Subcutaneous infusion/injection port needle
OBALON® Placebo Capsule HPMC - component for use with the OBALON® Balloon System
Reshape Lifesciences Inc.
7650-0002
Not in Commercial Distribution

  • 20859810006085 ()
  • 00859810006081 ()
  • 10859810006088 ()


  • Appetite-suppression gastric balloon
OBALON® Placebo Capsule - component for use with the OBALON® Balloon System
Reshape Lifesciences Inc.
7150-0003
Not in Commercial Distribution

  • 10859810006002 ()
  • 00859810006005 ()
  • 20859810006009 ()


  • Appetite-suppression gastric balloon
OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
Reshape Lifesciences Inc.
9410-0001
Not in Commercial Distribution

  • 10859810006224 ()
  • 00859810006227 ()


  • Appetite-suppression gastric balloon deployment device/set
  • Appetite-suppression gastric balloon
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