Citric Acid 329

GUDID 00883205105523

Citric Acid 20% Solution IndiSpense Refill

ULTRADENT PRODUCTS, INC.

Endodontic reaming aid material
Primary Device ID00883205105523
NIH Device Record Key925d13d9-ed57-429e-a5b1-4c49ce95d316
Commercial Distribution StatusIn Commercial Distribution
Brand NameCitric Acid
Version Model Number329
Catalog Number329
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
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 Usefalse
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

Customer Support Contacts

Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205105523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJIRADIOIMMUNOASSAY, KANAMYCIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-10

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