Transducer Cover

GUDID 17350025911653

Vitrolife Sweden AB

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Primary Device ID17350025911653
NIH Device Record Keyd525c250-0cda-4375-a3f8-daf1eff8c5d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer Cover
Version Model Number14202
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count25
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350025911656 [Unit of Use]
GS117350025911653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEMImager, Ultrasonic Obstetric-Gynecologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-13

On-Brand Devices [Transducer Cover]

1735002591167714204
1735002591165314202
1735002591164614201

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