Follicle Aspiration Set Double Lumen

GUDID 17350025915415

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025915415
NIH Device Record Keyde3d2277-fb54-4e61-b9c5-5bc7dfa365cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set Double Lumen
Version Model Number17168
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
GS107350025915418 [Primary]
GS117350025915415 [Package]
Contains: 07350025915418
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 Double Lumen]

1735002591541517168
1735002591540817161
1735002591539217158
1735002591534717151
1735002591533017150
1735002591532317148
1735002591525517131
1735002591523117129
1735002591516317114
1735002591513217111
1735002591512517109
1735002591511817108
1735002591509517105
1735002591506417102

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