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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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SILICONE TUBE .040"x.085"x10FT
Bausch & Lomb Incorporated
N5941 5
In Commercial Distribution

  • 00757770428229 ()
N5941 5

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use
Neutral Electrode
Leonhard Lang GmbH
RO21 /5
In Commercial Distribution

  • 29005531591527 ()
  • 19005531591520 ()
  • 09005531591523 ()
  • 39005531591524 ()
RO21 /5

  • Electrosurgical return electrode, single-use
No Description
Leonhard Lang GmbH
FS-WA10C /5
In Commercial Distribution

  • 39005531000576 ()
  • 29005531000579 ()
  • 19005531000572 ()
  • 09005531000575 ()
FS-WA10C /5

  • Electrocardiographic electrode, single-use
DBC Sterile, disposable surgical stainless steel intradermal needles. 5 needles in foam per sealed bulk package. Box of 50 needles.
Dong Bang Medical co.,Ltd.
Dbc.Intra.5
In Commercial Distribution

  • 28800018900820 ()
  • 18800018900823 ()
  • 08800018900826 ()

  • 5.0 mm x 12 mm
Dbc.Intra.5

  • Acupuncture needle, single-use
Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00197998312274 ()
  • 00197998312267 ()
M8275026/5

  • Negative-pressure wound therapy open-abdomen dressing
Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00197998032615 ()
  • 00197998032608 ()
M8275026/5

  • Negative-pressure wound therapy open-abdomen dressing
Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope
Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor
TSO3 Inc
44020
In Commercial Distribution

  • 00690455440201 ()
44020

  • Biological sterilization indicator
The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
TSO3 Inc
44010
In Commercial Distribution

  • 00690455045604 ()
  • 00690455440102 ()
44010

  • Hydrogen peroxide device sterilant
The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
TSO3 Inc
44000-R
In Commercial Distribution

  • 00690455440003 ()
44000-R

  • Ozone/hydrogen peroxide sterilizer
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