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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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PDS - 10705031060913

Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
Z423H
In Commercial Distribution

  • 10705031060913 ()
  • 30705031060917 ()
Z423H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

PDS - 10705031060890

Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
Z422H
In Commercial Distribution

  • 10705031060890 ()
  • 30705031060894 ()
Z422H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

PDS - 10705031060876

Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
Z421H
In Commercial Distribution

  • 10705031060876 ()
  • 30705031060870 ()
Z421H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

PDS - 10705031060852

Undyed Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
Z416H
In Commercial Distribution

  • 10705031060852 ()
  • 30705031060856 ()
Z416H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

i-Thread - 48800056425297

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 - 48800056424221

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

PDS - 10705031231030

Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
D10174
In Commercial Distribution

  • 30705031231034 ()
  • 10705031231030 ()
D10174

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

PDS - 10705031231023

Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
D10169
In Commercial Distribution

  • 30705031231027 ()
  • 10705031231023 ()
D10169

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

PDS - 10705031231016

Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
D10168
In Commercial Distribution

  • 30705031231010 ()
  • 10705031231016 ()
D10168

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

ENDOKNOT - 10705031206496

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

  • 20705031206493 ()
  • 10705031206496 ()
ZK10C

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

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

Unimed - 06936735493715

ECG Monitor Trunk Cable Philips NEW Style
Unimed Medical Supplies, Inc.
NEPH2031-UE
In Commercial Distribution

  • 06936735493715 ()


  • Electrocardiographic lead set, reusable

Medline Industries, Inc. - 10195327598860

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

Honan Intraocular Pressure Reducer - 00851607007196

BLACK BULB W/ FILTER & RING (NEW STYLE)
LEBANON CORP, THE
560
In Commercial Distribution

  • 00851607007196 ()


  • Intraocular pressure-reducing compression system

Medline Industries, Inc. - 10889942379477

LEE PICC KIT W/ NEW GW & PREV
MEDLINE INDUSTRIES, INC.
PICCLEE41-01A
In Commercial Distribution

  • 10889942379477 ()
PICCLEE41-01A

  • General surgical procedure kit, medicated

Centurion - 00653160003857

NEW BRITAIN GENERAL HOSP FINE SUTURE SET
CENTURION MEDICAL PRODUCTS CORPORATION
SUT6525
In Commercial Distribution

  • 50653160003852 ()
  • 00653160003857 ()
SUT6525

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10887488616865

KIT,G 3 VALVE,NEW YORK HOSPIT
Cardinal Health 200, LLC
PCV2VR942
In Commercial Distribution

  • 50887488616863 ()
  • 10887488616865 ()
PCV2VR942

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488615455

KIT,G 3 CABG,NEW YORK HOSPITAL
Cardinal Health 200, LLC
PCV2CG922
In Commercial Distribution

  • 50887488615453 ()
  • 10887488615455 ()
PCV2CG922

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488610702

KIT,G3 CABG,NEW YORK HOSPITA P
Cardinal Health 200, LLC
PCV2CG93W
In Commercial Distribution

  • 50887488610700 ()
  • 10887488610702 ()
PCV2CG93W

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488610672

KIT,G3 VALVE,NEW YORK HOSPIT P
Cardinal Health 200, LLC
PCV2VR93R
In Commercial Distribution

  • 50887488610670 ()
  • 10887488610672 ()
PCV2VR93R

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488497563

G 3 VALVE,NEW YORK HOSPIT,KIT
Cardinal Health 200, LLC
PCV2VR93O
In Commercial Distribution

  • 50887488497561 ()
  • 10887488497563 ()
PCV2VR93O

  • Cardiothoracic surgical procedure kit, medicated, single-use
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