Ball-Point Applicators

GUDID 00615375005279

Disposable BallPoint Micro Applicators

METREX RESEARCH, LLC

Dental material application tool, single-use
Primary Device ID00615375005279
NIH Device Record Key857d0bca-a6ad-44ba-9743-df04a42ce78c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBall-Point Applicators
Version Model Number8300-FC
Company DUNS145963778
Company NameMETREX RESEARCH, LLC
Device Count250
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+18008411428
Emailcustomercare@kavokerrgroup.com
Phone+18008411428
Emailcustomercare@kavokerrgroup.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375005279 [Primary]
GS100615375007839 [Unit of Use]

FDA Product Code

KXRAPPLICATOR, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-08-31

On-Brand Devices [Ball-Point Applicators]

00615375005286Disposable BallPoint Micro Applicators
00615375005279Disposable BallPoint Micro Applicators

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