Gel Cord Clear Topical Hemostatic Gel ProPack 15840

GUDID 00310866000831

25% aluminum sulfate gel, 12 - 0.75g syringe; no color

PASCAL COMPANY, INC.

Gingival retraction solution
Primary Device ID00310866000831
NIH Device Record Key28c835dd-9563-41ab-8963-9c0c1c6b5db6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGel Cord Clear Topical Hemostatic Gel ProPack
Version Model Number15840
Catalog Number15840
Company DUNS009260217
Company NamePASCAL COMPANY, INC.
Device Count12
DM Exemptfalse
Pre-market Exempttrue
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

Customer Support Contacts

Phone8004268051
Emailpascal@pascaldental.com

Device Dimensions

Weight0.75 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100310866000831 [Primary]
GS100310866001715 [Unit of Use]

FDA Product Code

MVLCord, Retraction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-01
Device Publish Date2019-01-29

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