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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, 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

NEW METAL STRIPS - 14548161391771

NEW METAL STRIPS Assortment "B" Package, 12 strips, 1 strip of each width and each mesh
Gc America Inc.
000267
In Commercial Distribution

  • 14548161391771 ()
000267

  • Dental abrasive strip, single-use

NEW METAL STRIPS - 14548161391733

NEW METAL STRIPS Assortment "A" Package, #1000 Mesh Fine (four A, four B and four C widths) Yellow
Gc America Inc.
000263
In Commercial Distribution

  • 14548161391733 ()
000263

  • Dental abrasive strip, single-use

NEW METAL STRIPS - 14548161391696

NEW METAL STRIPS Assortment "A" Packages, #600 Mesh Medium, (four A, four B and four C widths) Green
Gc America Inc.
000259
In Commercial Distribution

  • 14548161391696 ()
000259

  • Dental abrasive strip, single-use

NEW METAL STRIPS - 14548161391658

NEW METAL STRIPS Assortment "A" Package, #300 Mesh Coarse, (four A, four B and four C widths), Blue
Gc America Inc.
000255
In Commercial Distribution

  • 14548161391658 ()
000255

  • Dental abrasive strip, single-use

NEW METAL STRIPS - 14548161391627

NEW METAL STRIPS Refill Package, Contains 12 strips, all one width, #200 Mesh A-Width Red
Gc America Inc.
000252
In Commercial Distribution

  • 14548161391627 ()
000252

  • Dental abrasive strip, single-use

NEW METAL STRIPS - 14548161391610

NEW METAL STRIPS Assortment "A" Package, #200 Mesh Extra Coarse (four A, four B and four C widths) Red
Gc America Inc.
000251
In Commercial Distribution

  • 14548161391610 ()
000251

  • Dental abrasive strip, single-use

VERSANT NEW BALANCE - 00882851339436

No Description
FGX INTERNATIONAL INC.
10307106.VER
In Commercial Distribution

  • 00882851339436 ()


  • Prescription spectacles

Mor-Medical New Era - 00858288006326

Deluxe New Era Patented Infection Control 18" Shower Commode Chair, with Open Front Soft Seat and Insert, Commode Pail, 3" All Locking Casters, 310 lbs. wt. capacity
Moroles Investments, LLC
DNE-310-3TWL
In Commercial Distribution

  • 00858288006326 ()


  • Commode, manual

Mor-Medical New Era - 00858288006203

Deluxe New Era Patented Infection Control 22" Shower Chair, with Open Front Soft Seat and Insert, Slide Out Commode Pail, 3" All Locking Casters, 385 lbs. wt. capacity
Moroles Investments, LLC
DNE-385-3TWL
In Commercial Distribution

  • 00858288006203 ()


  • Commode, manual

NEW CHOICE PLUS - 00667742001117

ONE STEP PREGNANCY TEST
SCI Medic, Inc.
00111
Not in Commercial Distribution

  • 00667742001117 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

JONES NEW YORK - 00884409264207

No Description
FGX INTERNATIONAL INC.
10212252.MID
In Commercial Distribution

  • 00884409264207 ()


  • Tinted non-prescription spectacles

A NEW DAY - 00884409126116

No Description
FGX INTERNATIONAL INC.
10204771.FTG
In Commercial Distribution

  • 00884409126116 ()


  • Tinted non-prescription spectacles

Mor-Medical New Era - 00850010988849

Deluxe New Era Patented Infection Control 26" Shower Chair, with Open Front Soft Seat and Insert, Double Drop Arms, Slide Out Commode Pail, 3" All Locking Casters, 385 lbs. wt. capacity
Moroles Investments, LLC
DNE-385-3TWL-DDA
In Commercial Distribution

  • 00850010988849 ()


  • Commode, manual

Mor-Medical New Era - 00850010988795

Deluxe New Era Transfer Board, Half Size: 31" L x 23" W x 1/4" Thick
Moroles Investments, LLC
DNE-TB-H
In Commercial Distribution

  • 00850010988795 ()


  • Patient transfer sliding board

Mor-Medical New Era - 00850010988788

Deluxe New Era Transfer Board, Standard Size: 71" L x 23.5" W x 1/4" Thick
Moroles Investments, LLC
DNE-TB-STD
In Commercial Distribution

  • 00850010988788 ()


  • Patient transfer sliding board

Mor-Medical New Era - 00850010988764

Deluxe New Era Patented Infection Control Soft Touch Shower Gurney with Elevated Head Section, 450 lbs. wt. capacity
Moroles Investments, LLC
DNE-SG10
In Commercial Distribution

  • 00850010988764 ()


  • Bathing stretcher

Mor-Medical New Era - 00850010988702

Deluxe New Era Patented Infection Control 20" Reclining Shower Chair with Open Front Soft Seat and Insert, Soft Touch Folding Footrest and Legrest, Slide Out Commode Pail, 3" All Locking Casters, 335 lbs. wt. capacity
Moroles Investments, LLC
DNE-REC-335-FF-LR-PAIL
In Commercial Distribution

  • 00850010988702 ()


  • Reclining chair
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