Slidding Stopper 1.4 - 1.9 OD INS-5323

GUDID 00815686020712

VERAN MEDICAL TECHNOLOGIES INC.

Surgical depth gauge, single-use
Primary Device ID00815686020712
NIH Device Record Key86bb5c58-ac15-4d6f-a25b-2a119a480c07
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlidding Stopper 1.4 - 1.9 OD
Version Model NumberINS-5323
Catalog NumberINS-5323
Company DUNS181714804
Company NameVERAN MEDICAL TECHNOLOGIES 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
GS100815686020712 [Primary]
GS110815686020719 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-08-31

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