Partial Zona Dissection (PZD) Pipette

GUDID 17350025911967

Vitrolife Sweden AB

User-induced micropipette User-induced micropipette User-induced micropipette User-induced micropipette User-induced micropipette
Primary Device ID17350025911967
NIH Device Record Keyaefd78ee-1f5e-497e-b006-3469e9024c88
Commercial Distribution StatusIn Commercial Distribution
Brand NamePartial Zona Dissection (PZD) Pipette
Version Model Number14328
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count5
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
GS107350025911960 [Unit of Use]
GS117350025911967 [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

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