Round ultrafit UFS060X5R

GUDID D746UFS060X5R1

Round ultrafit sheets .060" 5-pack

RAINTREE ESSIX INC.

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Primary Device IDD746UFS060X5R1
NIH Device Record Key2eaadf08-e386-49c5-bba3-9e2fdce04048
Commercial Distribution StatusIn Commercial Distribution
Brand NameRound ultrafit
Version Model NumberUFS060X5R
Catalog NumberUFS060X5R
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count5
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746UFS060X5R0 [Unit of Use]
HIBCCD746UFS060X5R1 [Primary]

FDA Product Code

MQCMouthguard, prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2016-09-24

On-Brand Devices [Round ultrafit]

D746UFS080X5R1Round ultrafit sheets .080" 5-pack
D746UFS080X25R1Round ultrafit sheets .080"x125mm. 25-pack
D746UFS060X5R1Round ultrafit sheets .060" 5-pack
D746UFS060X50R1Round ultrafit sheets .060" 50-pack
D746UFS060X25R1Round ultrafit sheets .060"x125mm. 25-pack
D746UFS040X10R1Round ultrafit sheets .040"x125mm. 10-pack
D746UFS040X100R1Round ultrafit sheets .040"x125mm. 100-pack

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