Clean Ultrasound Probe Cover

GUDID 09350855000290

NANOSONICS LIMITED

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Primary Device ID09350855000290
NIH Device Record Key02935dfd-c8bf-46fc-ad73-7ec7fbe90254
Commercial Distribution StatusIn Commercial Distribution
Brand NameClean Ultrasound Probe Cover
Version Model NumberN00102
Company DUNS741021943
Company NameNANOSONICS LIMITED
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109350855000290 [Primary]
GS109350855000405 [Unit of Use]

FDA Product Code

FFFCover, Biopsy Forceps

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-17
Device Publish Date2019-07-09

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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)

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