Magnesium Gen.2 06407358190

GUDID 04015630930821

Roche Diagnostics GmbH

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Primary Device ID04015630930821
NIH Device Record Key93fc6cec-eee2-428a-a93d-1edc8b02aa58
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagnesium Gen.2
Version Model Number6407358190
Catalog Number06407358190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630930821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JGJPHOTOMETRIC METHOD, MAGNESIUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [Magnesium Gen.2]

0761333616943808900019190
0761333612141208058016190
040156309308216407358190
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