Follicle Aspiration Set, Double Lumen

GUDID 17350025914111

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025914111
NIH Device Record Key52bf18f8-bc82-4f25-a82a-a08cf20293ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set, Double Lumen
Version Model Number14168
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
GS107350025914114 [Primary]
GS117350025914111 [Package]
Contains: 07350025914114
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, Double Lumen]

1735002591411114168
1735002591160814161
1735002591157814158
1735002591150914151
1735002591149314150
1735002591147914148
1735002591130114131
1735002591128814129
1735002591113414114
1735002591110314111
1735002591108014109
1735002591107314108
1735002591104214105
0735002591101414102

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