trophon Curved Probe Positioner N00099

GUDID 09350855000566

Curved Probe Positioner

NANOSONICS LIMITED

Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder Electrical cable/lead holder
Primary Device ID09350855000566
NIH Device Record Keydc7eaa24-60a0-47a7-b82c-2a3b1c025d43
Commercial Distribution StatusIn Commercial Distribution
Brand Nametrophon Curved Probe Positioner
Version Model NumberN00099
Catalog NumberN00099
Company DUNS741021943
Company NameNANOSONICS LIMITED
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us
Phone844-876-7466
Emailcustomerservice@nanosonics.us

Device Identifiers

Device Issuing AgencyDevice ID
GS109350855000559 [Primary]
GS109350855000566 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-18
Device Publish Date2022-07-08

Devices Manufactured by NANOSONICS LIMITED

09350855000566 - trophon Curved Probe Positioner2022-07-18Curved Probe Positioner
09350855000566 - trophon Curved Probe Positioner2022-07-18 Curved Probe Positioner
09350855000542 - trophon Chemical Indicator2022-05-20 Chemical Indicator
09350855000047 - Trophon Chemical Indicator2021-02-19 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)
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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