EndoraGard

GUDID 00615375001721

Disposable Tooth Protector

Kerr Corporation

Intubation teeth protector
Primary Device ID00615375001721
NIH Device Record Keyf5824f15-034a-4f51-90f5-1948590c1bd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoraGard
Version Model Number29520DX
Company DUNS199354556
Company NameKerr Corporation
Device Count50
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375001721 [Primary]
GS100615375008409 [Unit of Use]

FDA Product Code

BRWPROTECTOR, DENTAL

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 Date2017-08-31

Devices Manufactured by Kerr Corporation

00195062037979 - Rubber Base Adhesive2024-11-04 Impression adhesive for Permlastic.
00841396118630 - Permlastic2024-11-04 Impression material base, regular bodied
00841396118647 - Permlastic2024-11-04 Impression material catalyst, regular bodied
00841396118654 - Permlastic2024-11-04 Impression material base, heavy bodied
00841396118661 - Permlastic2024-11-04 Impression material catalyst, heavy bodied
00841396118678 - Permlastic2024-11-04 Impression material base, light bodied
00841396118685 - Permlastic2024-11-04 Impression material catalyst, light bodied
00841396118708 - Permlastic2024-11-04 Impression material, standard package, heavy bodied (base and catalyst)

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