Follicle Aspiration Set Single Lumen, Luer

GUDID 17350025915293

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025915293
NIH Device Record Keyec997319-c758-4e83-8cba-4e69b999e4ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set Single Lumen, Luer
Version Model Number17140
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count1
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
GS107350025915296 [Primary]
GS117350025915293 [Package]
Contains: 07350025915296
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQENeedle, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

On-Brand Devices [ Follicle Aspiration Set Single Lumen, Luer]

1735002591536117154
1735002591535417152
1735002591531617147
1735002591529317140
1735002591528617137

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