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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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125-280 Solution™ for STERIZONE VP4 Sterilizer - 00690455440102

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

STERIZONE® VP4 Sterilizer - 00690455440003

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

STERIZONE® CI+ Chemical indicator - 00690455438109

The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
TSO3 Inc
43810-1
In Commercial Distribution

  • 00690455438109 ()
  • 00690455438116 ()
43810-1

  • Chemical/physical sterilization process indicator

STERIZONE® BI+ Self-contained Biological Indicator - 00690455426021

The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
TSO3 Inc
42602-1
In Commercial Distribution

  • 00690455426021 ()
  • 00690455750218 ()
42602-1

  • Biological sterilization indicator

IPD - 08435566613326

TPA Screw M1.8
IMPLANT PROTESIS DENTAL 2004 SL
TPA
In Commercial Distribution

  • 08435566613326 ()
IPD/FA-TR-50

  • Dental prosthesis/implant abutment screw

IPD - 08435566613319

Screw Ti Hex 1.25 M1.8 Tinite
IMPLANT PROTESIS DENTAL 2004 SL
TTN
In Commercial Distribution

  • 08435566613319 ()
IPD/FA-TR-00/TIN

  • Dental prosthesis/implant abutment screw

IPD - 08435566613296

Screw Ti Hex 1.25 M1.8
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566613296 ()
IPD/FA-TR-00

  • Dental prosthesis/implant abutment screw

IPD - 08435566613104

Cementing abutment Engaging 25° Ø 3,5 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566613104 ()
IPD/FA-PN-05

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566613098

Cementing abutment Engaging 25° Ø 3,5 H 1.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566613098 ()
IPD/FA-PN-04

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566613081

Cementing abutment Engaging 15° Ø 3,5 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566613081 ()
IPD/FA-PN-03

  • Dental implant suprastructure, permanent, preformed
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