trophon Wireless Ultrasound Probe Holder N05030-US

GUDID 09350855000573

Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Instrument Tag (UDI: 09350855000283)

NANOSONICS LIMITED

Device operating status label/tag, reusable
Primary Device ID09350855000573
NIH Device Record Key58669dec-429f-446c-ab89-aab64ecce578
Commercial Distribution StatusIn Commercial Distribution
Brand Nametrophon Wireless Ultrasound Probe Holder
Version Model NumberN05030-US
Catalog NumberN05030-US
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean and dry area away from potential contamination or damage.

Device Identifiers

Device Issuing AgencyDevice ID
GS109350855000511 [Unit of Use]
GS109350855000573 [Primary]

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 Date2024-11-04
Device Publish Date2024-10-25

Devices Manufactured by NANOSONICS LIMITED

09350855000573 - trophon Wireless Ultrasound Probe Holder2024-11-04Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Instrument Tag (UDI: 09350855000283)
09350855000573 - trophon Wireless Ultrasound Probe Holder2024-11-04 Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Inst
09350855000207 - trophon AcuTrace Operator Card2024-06-05 RFID Operator card
09350855000214 - trophon AcuTrace Medical Instrument Tag2024-06-05 RFID Medical Instrument tag
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)

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