Follicle Aspiration Set Single Lumen

GUDID 17350025915385

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025915385
NIH Device Record Keyf2dbc63c-8b66-443e-973d-2e556f0800ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set Single Lumen
Version Model Number17157
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
GS107350025915388 [Primary]
GS117350025915385 [Package]
Contains: 07350025915388
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 Date2017-09-25

On-Brand Devices [ Follicle Aspiration Set Single Lumen]

1735002591551417186
1735002591550717185
1735002591549117183
1735002591538517157
1735002591537817156
1735002591530917145
1735002591526217132
1735002591524817130
1735002591522417126
1735002591521717125
1735002591519417120
1735002591518717119
1735002591517017116
1735002591515617113
1735002591514917112
1735002591510117107
1735002591508817104
1735002591507117103
1735002591569917189

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