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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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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
GUM SCISSORS IRIS CURVED 11.5cm CVD NEW
Power Dental U.S.A. Inc.
N5920N
Not in Commercial Distribution

  • D943N5920N00 ()
N5920N

  • Dental surgical scissors
CALIPER CASTRO CLC 40L, 17cm STR NEW
Power Dental U.S.A. Inc.
N4613LN
In Commercial Distribution

  • D943N4613LN00 ()
N4613LN

  • General-purpose calliper, metallic
CALIPER CSTRO CLC 40C, 17cm CVD NEW
Power Dental U.S.A. Inc.
N4613LAN
In Commercial Distribution

  • D943N4613LAN00 ()
N4613LAN

  • General-purpose calliper, metallic
10 inch New Port Lateral Vaginal Retractor
Surgical Direct, Inc.
SD91508200
In Commercial Distribution

  • B382SD915082000 ()
SD91508200

  • Vaginal speculum, reusable
7 inch New Orleans Needle Holder, TC
Surgical Direct, Inc.
SD90544618
In Commercial Distribution

  • B382SD905446180 ()
SD90544618

  • Suturing needle holder, reusable
Abutment New Engaging H 3.0 JDEvolution Plus
J DENTAL CARE SRL
Abutment New Engaging H 3.0 JDEvolution Plus
In Commercial Distribution

  • 08055510179465 ()
EVTIB30NC:

  • Dental implant system
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