Clean Ultrasound Probe Cover

GUDID 09350855000290

NANOSONICS LIMITED

Electronic device storage cover, single-use

• Primary Device ID: 09350855000290
• NIH Device Record Key: 02935dfd-c8bf-46fc-ad73-7ec7fbe90254
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clean Ultrasound Probe Cover
• Version Model Number: N00102
• Company DUNS: 741021943
• Company Name: NANOSONICS LIMITED
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350855000290 [Primary]
GS1	09350855000405 [Unit of Use]

FDA Product Code

• FFF: Cover, Biopsy Forceps

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-17
• Device Publish Date: 2019-07-09

Devices Manufactured by NANOSONICS LIMITED

• 09350855000573 - trophon Wireless Ultrasound Probe Holder: 2024-11-04 Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Inst
• 09350855000207 - trophon AcuTrace Operator Card: 2024-06-05 RFID Operator card
• 09350855000214 - trophon AcuTrace Medical Instrument Tag: 2024-06-05 RFID Medical Instrument tag
• 09350855000566 - trophon Curved Probe Positioner: 2022-07-18 Curved Probe Positioner
• 09350855000542 - trophon Chemical Indicator: 2022-05-20 Chemical Indicator
• 09350855000047 - Trophon Chemical Indicator: 2021-02-19 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)
• 09350855000054 - Trophon Chemical Indicator: 2021-02-19 Chemical Indicator US SP-P18 (NNA VARIANT)
• 09350855000108 - Trophon EPR: 2020-09-09 Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)