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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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Quill - 00848782051519

Quill PDO,Violet,3-0,45cm,PS-1,Uni-Directional
Surgical Specialties México, S. de R.L. de C.V.
VLP-4160
In Commercial Distribution

  • 10848782051516 ()
  • 00848782051519 ()


  • Barbed polyester suture, non-antimicrobial

i-Thread - 08800056425329

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 - 08800056425305

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 - 08800056425299

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 - 08800056425183

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 - 08800056425176

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

i-Thread - 08800056424223

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

Angel Whole Blood Processing System - 00852714003071

Angel Whole Blood Processing System Machine (EU) New with 966003051 EU Case Label for New EU Machines
NUO THERAPEUTICS INC
976000101
In Commercial Distribution

  • 00852714003071 ()


  • Apheresis system

Sensimatic® - 00810000520046

New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)(Korea)
PARKELL, INC.
D601-K
Not in Commercial Distribution

  • 00810000520046 ()
D601-K

  • Electrosurgical return electrode, reusable

NEW CHOICE PLUS - 00677421001116

New Choice Plus One Step Pregnancy Test
SCI Medic, Inc.
00111
In Commercial Distribution

  • 00677421001116 ()


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