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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Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
AS-50
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813053 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
AM-50
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813046 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
AL-50
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813022 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
Not in Commercial Distribution

  • 00850054813121 ()
  • 00850054813008 ()
AS-25

  • General-purpose medical fibre padding
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
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
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
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent
Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent
Custom Ti Base Non-Engaging GM H 4.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630200 ()
IPD/RB-IR-07/3D

  • Dental implant suprastructure, permanent, preformed
Healing abutment Ø 5.7 H 5.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630132 ()
IPD/FA-DW-05

  • Dental implant suprastructure, temporary, preformed, single-use
Healing abutment Ø 5.7 H 3.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630125 ()
IPD/FA-DW-03

  • Dental implant suprastructure, temporary, preformed, single-use
Custom Ti Base Non-Engaging Ø 4.5/5.0 GH 2.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630095 ()
IPD/EA-IW-05/3D

  • Dental implant suprastructure, permanent, preformed
Custom Ti Base Engaging Ø 4.5/5.0 GH 2.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630088 ()
IPD/EA-IW-04/3D

  • Dental implant suprastructure, permanent, preformed
Open Tray Coping Screw Ø 3.0
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566630033 ()
IPD/AD-TT-00/C

  • Dental prosthesis/implant abutment screw analog, reusable
Digital analog Ø 4.3
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566629341 ()
IPD/JB-AW-00/3D

  • Dental implant analog
Analog Ø 4.3
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566629334 ()
IPD/JB-AW-00

  • Dental implant analog
Analog Ø 3.8
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566628979 ()
IPD/JB-AR-00

  • Dental implant analog
Analog Ø 3.3
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566628610 ()
IPD/JB-AN-00

  • Dental implant analog
Scan Micro Non-Engaging Ø 3.5 H 10.0 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566628566 ()
IPD/RD-SN-01

  • Dental implant abutment analog, intraoral-scanning, single-use
Temporary abutment Non-Engaging Ø 3.5 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566628542 ()
IPD/RD-PN-07

  • Dental implant suprastructure, temporary, preformed, single-use
Custom Ti Base Non-Engaging Ø 3.5 H 0.3 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566628528 ()
IPD/RD-IN-01/3D

  • Dental implant suprastructure, permanent, preformed
Healing abutment Ø 3.5 H 3.25 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566628504 ()
IPD/RD-DN-03

  • Dental implant suprastructure, temporary, preformed, single-use
Analog Ø 3.5 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566628405 ()
IPD/RD-AN-00

  • Dental implant analog
Digital analog RP
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566627460 ()
IPD/2A-AR-00/3D

  • Dental implant analog
Open Tray Coping Screw RP
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566627422 ()
IPD/1A-TR-00/C

  • Dental prosthesis/implant abutment screw analog, reusable
Analog RP
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566627057 ()
IPD/1A-AR-00

  • Dental implant analog
Open Tray Coping Screw Ø 4.8 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566627033 ()
IPD/RC-TR-00/C

  • Dental prosthesis/implant abutment screw analog, reusable
TPA Screw Ø 4.8 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
TPA
In Commercial Distribution

  • 08435566627026 ()
IPD/RC-TR-50

  • Dental prosthesis/implant abutment screw
Ti Screw TiN Ø 4.8 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
TTN
In Commercial Distribution

  • 08435566627019 ()
IPD/RC-TR-00/TIN

  • Dental prosthesis/implant abutment screw
Ti Screw Ø 4.8 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566627002 ()
IPD/RC-TR-00

  • Dental prosthesis/implant abutment screw
Scan abutment Engaging Ø 4.8 H 10.0 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566626999 ()
IPD/RC-SR-00

  • Dental implant abutment analog, intraoral-scanning, single-use
Analog Ø 4.8 GM abutment
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566626906 ()
IPD/RC-AR-00

  • Dental implant analog
Analog RP
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566626500 ()
IPD/RA-AW-00

  • Dental implant analog
Scan abutment Engaging RP H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566625220 ()
IPD/WA-SR-02

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan abutment Non-Engaging RP H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566625213 ()
IPD/WA-SR-01

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan abutment Engaging RP H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566625206 ()
IPD/WA-SR-00

  • Dental implant abutment analog, intraoral-scanning, single-use
Temporary abutment Non-Engaging Ø 4,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566625190 ()
IPD/WB-PR-07

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary abutment Engaging Ø 4,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566625183 ()
IPD/WB-PR-06

  • Dental implant suprastructure, temporary, preformed, single-use
Straight Multi-unit Ø 4,0 H 3.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566625138 ()
IPD/WB-MR-03

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 4,0 H 2.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566625121 ()
IPD/WB-MR-02

  • Dental implant suprastructure, permanent, preformed
Straight Multi-unit Ø 4,0 H 1.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566625114 ()
IPD/WB-MR-01

  • Dental implant suprastructure, permanent, preformed
Custom Ti Base Non-Engaging Ø 4,0 H 3.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566625077 ()
IPD/WB-IR-05/3D

  • Dental implant suprastructure, permanent, preformed
Custom Ti Base Engaging Ø 4,0 H 3.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566625060 ()
IPD/WB-IR-04/3D

  • Dental implant suprastructure, permanent, preformed
Custom Ti Base Non-Engaging Ø 4,0 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566625053 ()
IPD/WB-IR-03/3D

  • Dental implant suprastructure, permanent, preformed
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