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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 - 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

Power Dental U.S.A., Inc. - D943N5920N00

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

  • D943N5920N00 ()
N5920N

  • Dental surgical scissors

Power Dental U.S.A., Inc. - D943N4613LN00

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

  • D943N4613LN00 ()
N4613LN

  • General-purpose calliper, metallic

Power Dental U.S.A., Inc. - D943N4613LAN00

CALIPER CSTRO CLC 40C, 17cm CVD NEW
Power Dental U.S.A. Inc.
N4613LAN
In Commercial Distribution

  • D943N4613LAN00 ()
N4613LAN

  • General-purpose calliper, metallic

HELMUT ZEPF - EZPF17690210

ROOT ELEVATOR FIG 77R NEW DESIGN ÖGRAM
Helmut Zepf Medizintechnik GmbH
17.690.21
In Commercial Distribution

  • EZPF17690210 ()
17.690.21

  • Dental elevator, tooth/root

HELMUT ZEPF - EZPF17690200

ROOT ELEVATOR FIG 30 NEW DESIGN ÖGRAM
Helmut Zepf Medizintechnik GmbH
17.690.20
In Commercial Distribution

  • EZPF17690200 ()
17.690.20

  • Dental elevator, tooth/root

HELMUT ZEPF - EZPF17690190

ROOT ELEVATOR FIG 29 NEW DESIGN ÖGRAM
Helmut Zepf Medizintechnik GmbH
17.690.19
In Commercial Distribution

  • EZPF17690190 ()
17.690.19

  • Dental elevator, tooth/root
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