ROOT LABS - PUTTY RL300

GUDID 00818524020066

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

CROWN DELTA CORPORATION

Silicone dental impression material
Primary Device ID00818524020066
NIH Device Record Keye9968e84-7fa3-4efe-9a07-f85b1a8788d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameROOT LABS - PUTTY
Version Model NumberRL300
Catalog NumberRL300
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
GS100818524020066 [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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