ROOT LABS - PUTTY RL320

GUDID 00818524020059

ROOT LABS, AUTO-ZONED, VINYL PUTTY, ECONO SIZE

CROWN DELTA CORPORATION

Silicone dental impression material
Primary Device ID00818524020059
NIH Device Record Key9ae65d4e-0b2e-40f0-883c-8172fcbb996f
Commercial Distribution StatusIn Commercial Distribution
Brand NameROOT LABS - PUTTY
Version Model NumberRL320
Catalog NumberRL320
Company DUNS030479000
Company NameCROWN DELTA CORPORATION
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818524020059 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-01

On-Brand Devices [ROOT LABS - PUTTY]

00818524020066ROOT LABS, AUTO-ZONED, VINYL PUTTY, REG SIZE
00818524020059ROOT LABS, AUTO-ZONED, VINYL PUTTY, ECONO SIZE

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