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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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ENDOKNOT PDS*II VL MONO DOM PRT - 3PL
Ethicon Inc.
ZK10C
Not in Commercial Distribution

  • 20705031206493 ()
  • 10705031206496 ()
ZK10C

  • 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
Not in Commercial Distribution

  • 48800056425297 ()

  • 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.
FCL19100E160
Not in Commercial Distribution

  • 48800056424221 ()

  • Length: 160 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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 (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
RHK, US, NEW MTO RIGHT HEART K
MEDLINE INDUSTRIES, INC.
VASC1490
In Commercial Distribution

  • 40195327598861 ()
  • 10195327598860 ()
VASC1490

  • General surgical procedure kit, non-medicated, single-use
New Choice Plus One Step Pregnancy Test
SCI Medic, Inc.
00111
In Commercial Distribution

  • 00677421001116 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
New universal cuff with connector for WMTBPA-240BT
WAL-MART STORES, INC.
WMTBPA-CUFF33
In Commercial Distribution

  • 04719872489146 ()
  • 14719872489143 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
MTO EMBOLISM KIT - NEW YORK HOSPITAL PG
MEDLINE INDUSTRIES, INC.
65140155
In Commercial Distribution

  • 10193489062045 ()
65140155

  • Angiography kit
MTO PED KIT EMANUEL HOSP NEW TOWER
MEDLINE INDUSTRIES, INC.
63050194
In Commercial Distribution

  • 20193489057994 ()
  • 10193489057997 ()
63050194

  • Angiography kit
MTO TAVR KIT EMANUEL HOSP NEW TOWER
MEDLINE INDUSTRIES, INC.
63050193
In Commercial Distribution

  • 20193489057987 ()
  • 10193489057980 ()
63050193

  • Angiography kit
MTO ACC KIT EMANUEL HOSP NEW TOWER
MEDLINE INDUSTRIES, INC.
63050192
In Commercial Distribution

  • 20193489057970 ()
  • 10193489057973 ()
63050192

  • Angiography kit
MTO R/H KIT-UNIVERSITY OF NEW MEXICO
MEDLINE INDUSTRIES, INC.
60210625
In Commercial Distribution

  • 20193489052180 ()
  • 10193489052183 ()
60210625

  • Angiography kit
MTS CUST 3V-YALE NEW HAVEN HOSP PG
MEDLINE INDUSTRIES, INC.
60250022
In Commercial Distribution

  • 20193489053392 ()
  • 10193489053395 ()
60250022

  • Angiography kit
MTS 5V W/BIFUR SPIKE-YALE NEW HAVEN
MEDLINE INDUSTRIES, INC.
60250021
In Commercial Distribution

  • 20193489053385 ()
  • 10193489053388 ()
60250021

  • Angiography kit
MTO PROTECTION STATION KIT NEW HANOVER K
MEDLINE INDUSTRIES, INC.
601413911
In Commercial Distribution

  • 20193489071624 ()
  • 10193489071627 ()
601413911

  • Angiography kit
MTS NEURO KIT NEW ENGLAND MED CTR
MEDLINE INDUSTRIES, INC.
601400110
In Commercial Distribution

  • 20193489071334 ()
  • 10193489071337 ()
601400110

  • Angiography kit
MTS NEW LAB AUTOMATE SYS KIT-SAN JUAN
MEDLINE INDUSTRIES, INC.
601322911
In Commercial Distribution

  • 20193489071280 ()
  • 10193489071283 ()
601322911

  • Angiography kit
MTS 135 CONTRAST SPIKE NEW ENGLAND MED
MEDLINE INDUSTRIES, INC.
60140013
In Commercial Distribution

  • 20193489047810 ()
  • 10193489047813 ()
60140013

  • Angiography kit
NEW TRANSPARENT SILICONE MASK SIZE#4.ADULT
BESMED HEALTH BUSINESS CORP.
SM-86543
In Commercial Distribution

  • 04716770865430 ()


  • Cardiopulmonary resuscitation mask, reusable
Nicore to New NK Spo2 Patient Cable
Advantage Medical Electronics, LLC
CB-60103R
In Commercial Distribution

  • 00849593003025 ()


  • Electrical-only medical device connection cable, reusable
ACCY DB-2040 NEXFRAME NEW QTS FACILTY US
MEDTRONIC, INC.
DB-2040
In Commercial Distribution

  • 00643169214811 ()


  • Neurological stereotactic surgery system
NEW SHIELD FNL PKG KIT 10 CT
MEDLINE INDUSTRIES, INC.
DYNJ63777A
In Commercial Distribution

  • 40193489393478 ()
  • 10193489393477 ()
DYNJ63777A

  • General surgical procedure kit, non-medicated, single-use
NEW SHIELD FINAL PKG KIT 20 CT
MEDLINE INDUSTRIES, INC.
DYNJ63894A
In Commercial Distribution

  • 40193489393461 ()
  • 10193489393460 ()
DYNJ63894A

  • General surgical procedure kit, non-medicated, single-use
ECG Monitor Trunk Cable Philips NEW Style
Unimed Medical Supplies, Inc.
NEPH2031-UE
In Commercial Distribution

  • 06936735493715 ()


  • Electrocardiographic lead set, reusable
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