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

  • 10705031060913 ()
  • 30705031060917 ()
Z423H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
Z422H
In Commercial Distribution

  • 10705031060890 ()
  • 30705031060894 ()
Z422H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
Z421H
In Commercial Distribution

  • 10705031060876 ()
  • 30705031060870 ()
Z421H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Undyed Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
Z416H
In Commercial Distribution

  • 10705031060852 ()
  • 30705031060856 ()
Z416H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
D10174
In Commercial Distribution

  • 30705031231034 ()
  • 10705031231030 ()
D10174

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
Ethicon Inc.
D10169
In Commercial Distribution

  • 30705031231027 ()
  • 10705031231023 ()
D10169

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
Ethicon Inc.
D10168
In Commercial Distribution

  • 30705031231010 ()
  • 10705031231016 ()
D10168

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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
RD® QUICK LOAD® SUTURE, 2-0 MONOGLIDE® DUO
LSI Solutions, Inc.
023387
In Commercial Distribution

  • 10850012846526 ()
  • 00850012846529 ()
023387

  • Polyester suture, non-bioabsorbable, multifilament
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
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
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
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
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
BLACK BULB W/ FILTER & RING (NEW STYLE)
LEBANON CORP, THE
560
In Commercial Distribution

  • 00851607007196 ()


  • Intraocular pressure-reducing compression system
NEW BRITAIN GENERAL HOSP FINE SUTURE SET
CENTURION MEDICAL PRODUCTS CORPORATION
SUT6525
In Commercial Distribution

  • 50653160003852 ()
  • 00653160003857 ()
SUT6525

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

  • 06936735493715 ()


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

  • 10889942379477 ()
PICCLEE41-01A

  • General surgical procedure kit, medicated
NEW HEAD VISE II, CASE OF 50
MORRISON MEDICAL, LTD
1465-50
In Commercial Distribution

  • 00647921146525 ()
  • 00647921146570 ()
1465-50

  • Limb/torso/head restraint, single-use
NEW HEAD VISE II, CASE OF 10
MORRISON MEDICAL, LTD
1465-10
In Commercial Distribution

  • 00647921146518 ()
  • 00647921146563 ()
1465-10

  • Head/neck immobilizer, reusable
NEW SHIELD FNL PKG KIT 10 CT
MEDLINE INDUSTRIES, INC.
DYNJ63777
In Commercial Distribution

  • 40193489760539 ()
  • 10193489760538 ()
DYNJ63777

  • General surgical procedure kit, non-medicated, single-use
NEW SHIELD FINAL PKG KIT 20 CT
MEDLINE INDUSTRIES, INC.
DYNJ63894
In Commercial Distribution

  • 10193489771541 ()
DYNJ63894

  • 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
KIT,NEW BABY,ST HELENA,10 CS
Cardinal Health 200, LLC
BAB691659A
In Commercial Distribution

  • 50885425773761 ()
  • 10885425773763 ()
BAB691659A

  • General surgical procedure kit, non-medicated, single-use
NEW ORLEANS LENS LOOP SINGLE ENDED TITANIUM
SONTEC INSTRUMENTS, INC.
T12-4330
In Commercial Distribution

  • 00192896013490 ()

  • Length: 5.25 Inch
T12-4330

  • Lens loop, reusable
LIF HANDHELD RETRACTOR, 20 MM, NEW HANDLE
ALPHATEC SPINE, INC.
CI-11265-20
In Commercial Distribution

  • 00840180516577 ()


  • Hand-held surgical retractor, reusable
LIF HANDHELD RETRACTOR, 10 MM, NEW HANDLE
ALPHATEC SPINE, INC.
CI-11265-10
In Commercial Distribution

  • 00840180516560 ()


  • Hand-held surgical retractor, reusable
New 6.0 MM IN-Situ Sagittal Bender, Right
ALPHATEC SPINE, INC.
CI-11196-R
In Commercial Distribution

  • 00840180513422 ()


  • Manual orthopaedic bender, reusable
New 6.0 MM IN-Situ Sagittal Bender, Left
ALPHATEC SPINE, INC.
CI-11196-L
In Commercial Distribution

  • 00840180513415 ()


  • Manual orthopaedic bender, reusable
870 DR NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00840682140836 ()


  • Stationary gamma camera system
  • Full-body CT system
D670 CZT GANTRY 7.25mm WITH NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682139380 ()


  • Full-body CT system
  • Stationary gamma camera system
D670 PRO NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 PRO
In Commercial Distribution

  • 00840682139373 ()


  • Stationary gamma camera system
  • Full-body CT system
CLOWARD NEW TYPE BLADE RETR, 3", 20MM
SURGIX MEDICAL LLC
G2N52305
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 20 mm
G2N52305

  • Hand-held surgical retractor, reusable
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