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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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Airo™ CPAP Mask Liners - 00850054813367

Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813329

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
EVAL-AL-50
In Commercial Distribution

  • 00850054813299 ()
  • 00850054813329 ()
EVAL-AL-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813084

Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
AS-100
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813084 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813077

Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
AM-100
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813077 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813060

Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
AL-100
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813060 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813053

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 - 00850054813046

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 - 00850054813022

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 - 00850054813008

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

STERIZONE® VP4 Test Pack Kit - 00690455440201

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

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

OPELAIII Attached Belt (3L) - 14589864500350

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500350 ()


  • Head-worn lamp

OPELAIII COOLMAX® Comfort Inner Pads - 14589864500336

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500336 ()


  • Head-worn lamp

OPELAIII calibration kit - 14589864500312

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500312 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500282

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500282 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500275

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500275 ()


  • Head-worn lamp

OPELAIII Hard Case - 14589864500237

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp

OPELAIII Cord Clip (Large) - 14589864500213

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp

OPELAIII Cord Clip (Small) - 14589864500206

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp

OPELAIII Antibacterial Urethane Pad - 14589864500176

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp

OPELAIII Storage Bag (with calibration kit) - 14589864500169

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp

OPELAIII Attached Belt (LL) - 14589864500152

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500152 ()


  • Head-worn lamp

OPELAIII Attached Belt (M-L) - 14589864500145

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500145 ()


  • Head-worn lamp

OPELAIII Dedicated AC Adapter - 14589864500138

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500138 ()


  • Head-worn lamp

OPELAIII Battery Unit - 14589864500121

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500121 ()


  • Head-worn lamp

OPELAIII Main Unit - 14589864500114

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500114 ()


  • Head-worn lamp

OPELAIII Standard Package - 14589864500107

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500107 ()


  • Head-worn lamp

IPD - 08435566618178

Screwdriver Multi-unit L 20
IMPLANT PROTESIS DENTAL 2004 SL
LL
In Commercial Distribution

  • 08435566618178 ()
IPD/LL-AB-00

  • Surgical screwdriver, reusable

IPD - 08435566618123

TPA Screw Ø 3,0/3,5/4,5/5,7
IMPLANT PROTESIS DENTAL 2004 SL
TPA
In Commercial Distribution

  • 08435566618123 ()
IPD/LB-TR-50

  • Dental prosthesis/implant abutment screw

IPD - 08435566618116

Ti Screw TiN Ø 3,0/3,5/4,5/5,7
IMPLANT PROTESIS DENTAL 2004 SL
TTN
In Commercial Distribution

  • 08435566618116 ()
IPD/LB-TR-00/TIN

  • Dental prosthesis/implant abutment screw

IPD - 08435566618109

Open Tray Coping Screw Ø 3,0/3,5/4,5/5,7
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566618109 ()
IPD/LB-TR-00/C

  • Dental prosthesis/implant abutment screw analog, reusable

IPD - 08435566618093

Ti Screw Ø 3,0/3.5/4.5/5.7
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566618093 ()
IPD/LB-TR-00

  • Dental prosthesis/implant abutment screw

IPD - 08435566618086

Scan abutment Engaging Ø 5,7 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566618086 ()
IPD/LB-SW-02

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566618079

Scan abutment Non-Engaging Ø 5,7 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566618079 ()
IPD/LB-SW-01

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566618062

Scan abutment Engaging Ø 5,7 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566618062 ()
IPD/LB-SW-00

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566618055

Scan abutment Engaging Ø 3,0 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566618055 ()
IPD/LB-ST-02

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566618048

Scan abutment Non-Engaging Ø 3,0 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566618048 ()
IPD/LB-ST-01

  • Dental implant abutment analog, intraoral-scanning, single-use
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