OCTAX Laser Shot 19310/0148

GUDID 04260502101483

Octax Microscience GmbH

Assisted reproduction laser system
Primary Device ID04260502101483
NIH Device Record Keyc4e210ae-5721-40c0-bbe0-990d675a2063
Commercial Distribution Discontinuation2017-05-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOCTAX Laser Shot
Version Model Number19310/0148
Catalog Number19310/0148
Company DUNS314169074
Company NameOctax Microscience GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260502101483 [Primary]

FDA Product Code

MRXSystem, Assisted Reproduction Laser

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-03
Device Publish Date2016-09-22

Devices Manufactured by Octax Microscience GmbH

04260604170011 - Octax LaserShot M2020-05-19 The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The Laser
04260604170028 - Octax NaviLase2020-05-19 This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static
04260502101483 - OCTAX Laser Shot2019-05-03
04260502101483 - OCTAX Laser Shot2019-05-03

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