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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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Endoform Myriad - 09421905067393

Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.
AROA BIOSURGERY LIMITED
MR05LG1020
Not in Commercial Distribution


  • 10 x 20 cm
SR05LG1020US

  • Animal-derived wound matrix dressing
  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

LAP-BAND® AP System Large with RapidPort® EZ - 00850007764654

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 System Standard with RapidPort® EZ - 00850007764609

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


  • Standard
C-2360

  • Gastric band

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

Streamline TL Spinal Fixation System - 00191083021898

PEDICLE SCREW, POLYAXIAL
Xtant Medical Holdings, Inc.
01-PA-75-75
Not in Commercial Distribution

01-PA-75-75

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083021881

PEDICLE SCREW, POLYAXIAL
Xtant Medical Holdings, Inc.
01-PA-75-70
Not in Commercial Distribution

01-PA-75-70

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083021874

PEDICLE SCREW, POLYAXIAL
Xtant Medical Holdings, Inc.
01-PA-75-65
Not in Commercial Distribution

01-PA-75-65

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083021850

PEDICLE SCREW, POLYAXIAL
Xtant Medical Holdings, Inc.
01-PA-75-55
Not in Commercial Distribution

01-PA-75-55

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083021843

PEDICLE SCREW, POLYAXIAL
Xtant Medical Holdings, Inc.
01-PA-75-50
Not in Commercial Distribution

01-PA-75-50

  • Spinal bone screw, non-bioabsorbable
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