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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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MONOPLUS 5/0 (1) 70CM HR13B (M) DDP
B BRAUN SURGICAL SA
C0024163
Not in Commercial Distribution

  • 04046955078943 ()
  • 04046955078936 ()

  • Thread Material : polydioxanone
  • Length: 70.0 Centimeter
  • Size of Thread (USP - Others) : 5/0
C0024163

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS 6/0 (0,7) 70CM HR13B (M) DDP
B BRAUN SURGICAL SA
C0024162
Not in Commercial Distribution

  • 04046955078127 ()
  • 04046955078110 ()

  • Size of Thread (USP - Others) : 6/0
  • Thread Material : polydioxanone
  • Length: 70.0 Centimeter
C0024162

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCHL19100E160
In Commercial Distribution

  • 08800056425329 ()
  • 48800056425327 ()
  • 88800056425325 ()

  • Length: 160 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCHL1960E90
In Commercial Distribution

  • 08800056425305 ()
  • 48800056425303 ()
  • 88800056425301 ()

  • Length: 90 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCL18100C160
In Commercial Distribution

  • 08800056425299 ()
  • 48800056465293 ()
  • 88800056425295 ()

  • Length: 120 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCRL1970E162
In Commercial Distribution

  • 08800056425183 ()
  • 48800056425181 ()
  • 88800056425189 ()

  • Length: 162 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCRL18100C185
In Commercial Distribution

  • 08800056425176 ()
  • 48800056425174 ()
  • 88800056425172 ()

  • Length: 185 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Determined based on the confidentiality designation assigned to the proprietary brand name associated to the listing number in the Device Registration and Listing Module(DRLM) database. In order to make changes to the Public Release status, please review your confidentiality designation in DRLM.
Hyundae Meditech Co., Ltd.
FCL19100E160
In Commercial Distribution

  • 08800056424223 ()
  • 48800056464227 ()
  • 88800056424229 ()

  • Length: 160 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Suture
RIVERPOINT MEDICAL, LLC
M970
In Commercial Distribution

  • 10840277409062 ()
  • 00840277409065 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Suture
RIVERPOINT MEDICAL, LLC
M468
In Commercial Distribution

  • 10840277409055 ()
  • 00840277409058 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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