Dynasty Acrylics 3748801

GUDID D79337488011

DYNASTY ACR PDR 99 HC (1# EACH)

GARRECO, LLC

Dental appliance fabrication material, cured
Primary Device IDD79337488011
NIH Device Record Key455e023a-105c-4ffc-b7d4-57272342e260
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynasty Acrylics
Version Model Number3748801
Catalog Number3748801
Company DUNS364004762
Company NameGARRECO, LLC
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79337488010 [Primary]
HIBCCD79337488011 [Package]
Contains: D79337488010
Package: [4 Units]
In Commercial Distribution

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

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 Date2016-09-25

On-Brand Devices [Dynasty Acrylics]

D79337488200Dynasty 99 20lb
D79337488051DYNASTY ACR PDR 99 HC (5# EACH)
D79337488011DYNASTY ACR PDR 99 HC (1# EACH)

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