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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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LAP-BAND System Access Port II Kit - 10811955020114

Access Port II Kit 0-10CC
Apollo Endosurgery, Inc.
B-2105
Not in Commercial Distribution

  • 10811955020114 ()

  • 0-10 cc
B-2105

  • Gastric band access port kit

LAP-BAND System Access Port I Kit - 10811955020107

Access Port I Kit 0-10CC
Apollo Endosurgery, Inc.
B-2104
Not in Commercial Distribution

  • 10811955020107 ()

  • 0-10 cc
B-2104

  • Gastric band access port kit

LAP-BAND System Access Port II Kit - 10811955020091

ACCESS PORT II KIT
Apollo Endosurgery, Inc.
B-2103
Not in Commercial Distribution

  • 10811955020091 ()

  • 9.75/10.0 cm
B-2103

  • Gastric band access port kit

LAP-BAND System Access Port I Kit - 10811955020084

Access Port Kit
Apollo Endosurgery, Inc.
B-2101
Not in Commercial Distribution

  • 10811955020084 ()

  • 9.75/10.0 cm
B-2101

  • Gastric band access port kit

ATLAS Review for i. Profiler plus - 04250668606632

N/A
Carl Zeiss Vision GmbH
000000-2360-422
In Commercial Distribution

  • 04250668606632 ()
000000-2360-422

  • Corneal topography system application software

NA - 20705036004018

Gastric Band Sutureless Port and Applier
Obtech Medical Sàrl
RLZPT2
Not in Commercial Distribution

  • 30705036004015 ()
  • 20705036004018 ()
RLZPT2

  • Gastric band access port kit

ReShape Lap-Band® 2.0, FLEX & Access Port, Large - 00850007764555

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 - 00850007764548

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 for use with LAP-BAND® AP System Large - 00850007764067

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 for use with LAP-BAND® AP System Standard - 00850007764043

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

CAIRE Diagnostics - 00860008017949

Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New Zealand AC Power Cord Cable, Australia/New Zealand - PN 415-0010
Caire Diagnostics Inc.
Fenom Pro, Australia/New Zealand
In Commercial Distribution

  • 00860008017949 ()
900-0012

  • Diagnostic spirometer, professional

CoolTouch - 00859932006327

Pullback Device
NEW STAR LASERS, INC.
7435-0254
Not in Commercial Distribution

  • 00859932006327 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006310

Pullback Device
NEW STAR LASERS, INC.
R7435-0254
Not in Commercial Distribution

  • 00859932006310 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006303

Cryogen Cooling
NEW STAR LASERS, INC.
7435-0200
Not in Commercial Distribution

  • 10859932006300 ()
  • 00859932006303 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006297

Cryogen Cooling
NEW STAR LASERS, INC.
9000-0460
Not in Commercial Distribution

  • 10859932006294 ()
  • 00859932006297 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006266

Pullback Device
NEW STAR LASERS, INC.
7435-0060
Not in Commercial Distribution

  • 00859932006266 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006259

Pullback Device
NEW STAR LASERS, INC.
R7435-0060
Not in Commercial Distribution

  • 00859932006259 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006181

Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0046
Not in Commercial Distribution

  • 00859932006181 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006150

Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0049
Not in Commercial Distribution

  • 00859932006150 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006143

Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0018
Not in Commercial Distribution

  • 00859932006143 ()


  • General/multiple surgical solid-state laser system
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