Follicle Aspiration Set, Single Lumen, Luer

GUDID 17350025911462

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025911462
NIH Device Record Key3647eb05-df56-409d-8a86-3778f18bc03d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set, Single Lumen, Luer
Version Model Number14147
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
GS107350025911465 [Primary]
GS117350025911462 [Package]
Contains: 07350025911465
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 Date2016-09-09

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

1735002591153014154
1735002591146214147
1735002591139414140
1735002591136314137

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