Follicle Aspiration Set, Single Lumen

GUDID 17350025911189

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use
Primary Device ID17350025911189
NIH Device Record Keyf84e09a0-df84-42b4-bc4b-42eeef4869cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameFollicle Aspiration Set, Single Lumen
Version Model Number14119
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
GS107350025911182 [Primary]
GS117350025911189 [Package]
Contains: 07350025911182
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]

1735002591485214183
1735002591424114169
1735002591156114157
1735002591155414156
1735002591144814145
1735002591138714186
1735002591137014185
1735002591134914135
1735002591131814132
1735002591129514130
1735002591125714126
1735002591124014125
1735002591119614120
1735002591118914119
1735002591115814116
1735002591112714113
1735002591111014112
1735002591106614107
1735002591103514104
0735002591102114103
1735002591100414101

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