R34 Low B12 15-1047AL

GUDID 00840075404477

Lonza Walkersville, Inc.

Ex vivo cell culture medium
Primary Device ID00840075404477
NIH Device Record Key535777d2-3dbc-4482-95b4-0a567b5d5b24
Commercial Distribution StatusIn Commercial Distribution
Brand NameR34 Low B12
Version Model Number15-1047AL
Catalog Number15-1047AL
Company DUNS609095955
Company NameLonza Walkersville, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840075404477 [Primary]

FDA Product Code

KITMedia And Components, Synthetic Cell And Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

On-Brand Devices [R34 Low B12]

0084007540449115-1052Y
0084007540447715-1047AL

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