ICSI Pipette

GUDID 17350025911806

Vitrolife Sweden AB

User-induced micropipette
Primary Device ID17350025911806
NIH Device Record Key8296e607-8fae-44fd-ad2c-5136f8142912
Commercial Distribution StatusIn Commercial Distribution
Brand NameICSI Pipette
Version Model Number14312
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count20
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
GS107350025911809 [Unit of Use]
GS117350025911806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQHMicrotools, Assisted Reproduction (Pipettes)

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 [ICSI Pipette]

1735002591217914349
1735002591210014342
1735002591206314338
1735002591194314326
1735002591189914321
1735002591180614312
1735002591178314310
1735002591172114304

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