Follicle Aspiration Set Reduced Single Lumen

GUDID 17350025915460

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025915460
NIH Device Record Key53d28f43-cdd1-4c70-a80e-a9d7785cb52d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set Reduced Single Lumen
Version Model Number17178
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
GS107350025915463 [Primary]
GS117350025915460 [Package]
Contains: 07350025915463
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 Date2018-01-05

On-Brand Devices [Follicle Aspiration Set Reduced Single Lumen]

1735002591546017178
1735002591545317177
1735002591544617176
1735002591543917175
1735002591568217188

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