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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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PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000039 ()

  • Area/Surface Area: 4 Square centimeter
  • Area/Surface Area: 54 Square centimeter
  • Area/Surface Area: 8 Square centimeter
  • Area/Surface Area: 25 Square centimeter


  • Collagen wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000022 ()

  • Area/Surface Area: 54 Square centimeter
  • Area/Surface Area: 8 Square centimeter
  • Area/Surface Area: 25 Square centimeter


  • Collagen wound matrix dressing
SWAB STICK,ALCOHOL3PK,STERILE
MEDLINE INDUSTRIES, INC.
APLS31055S
In Commercial Distribution

  • 20618407631051 ()
  • 00618407631057 ()
APLS31055S

  • Antiseptic skin swab
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-930
MENTOR TEXAS L.P.
SZUHE930
In Commercial Distribution

  • 10081317032738 ()
SZ-UHE-930

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1445
MENTOR TEXAS L.P.
SZUHE1445
In Commercial Distribution

  • 10081317032721 ()
SZ-UHE-1445

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1340
MENTOR TEXAS L.P.
SZUHE1340
In Commercial Distribution

  • 10081317032714 ()
SZ-UHE-1340

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1240
MENTOR TEXAS L.P.
SZUHE1240
In Commercial Distribution

  • 10081317032707 ()
SZ-UHE-1240

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1135
MENTOR TEXAS L.P.
SZUHE1135
In Commercial Distribution

  • 10081317032691 ()
SZ-UHE-1135

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1030
MENTOR TEXAS L.P.
SZUHE1030
In Commercial Distribution

  • 10081317032684 ()
SZ-UHE-1030

  • Invasive breast implant sizer, fixed, single-use
Breast Tissue Expander, Suture Tabs, Integral Injection Dome
MENTOR TEXAS L.P.
SCPX15THE
In Commercial Distribution

  • 10081317032332 ()
SCPX-15TH-E

  • Skin-port tissue expander
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