STENTube Lacrimal Intubation Set LIS052

GUDID 10634624815527

QUEST MEDICAL INC

Lacrimal intubation set
Primary Device ID10634624815527
NIH Device Record Key4e83ffab-ce1a-4f46-898d-9f35cb2c6d2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTENTube Lacrimal Intubation Set
Version Model NumberLIS052
Catalog NumberLIS052
Company DUNS041810693
Company NameQUEST MEDICAL INC
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 Datetrue
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
GS110634624815527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OKSLacrimal Stents And Intubation Sets

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2016-06-07

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