trophon Sonex-HL

GUDID 09350855000160

35% Hydrogen Peroxide Cartridge

NANOSONICS LIMITED

Medical device disinfectant Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent
Primary Device ID09350855000160
NIH Device Record Keyd311a195-0a26-43d6-b298-75e8b3315409
Commercial Distribution StatusIn Commercial Distribution
Brand Nametrophon Sonex-HL
Version Model NumberN05002
Company DUNS741021943
Company NameNANOSONICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100935085500025 [Package]
Contains: 09350855000146
Package: Inner Shipper [2 Units]
In Commercial Distribution
GS109350855000146 [Primary]
GS109350855000153 [Package]
Contains: 09350855000146
Package: Inner Shipper [6 Units]
In Commercial Distribution
GS109350855000160 [Package]
Contains: 09350855000153
Package: Outer Shipper [2 Units]
In Commercial Distribution
GS109350855000252 [Package]
Contains: 09350855000146
Package: Inner Shipper [2 Units]
In Commercial Distribution
GS109350855000269 [Package]
Contains: 09350855000252
Package: Outer Shipper [2 Units]
In Commercial Distribution

FDA Product Code

OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-24
Device Publish Date2018-06-15

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09350855000054 - Trophon Chemical Indicator2021-02-19 Chemical Indicator US SP-P18 (NNA VARIANT)
09350855000108 - Trophon EPR2020-09-09 Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
09350855000115 - Trophon EPR2020-09-09 Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
09350855000092 - Sonex-HL2020-09-09 Sonex-HL Each unit AHECC 2847.00.00 (NNA VARIANT)
09350855000139 - Trophon EPR2020-09-09 Trophon US Refurbished

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