Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD INS-5300

GUDID 00815686021214

VERAN MEDICAL TECHNOLOGIES INC.

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Primary Device ID00815686021214
NIH Device Record Key728581a3-11ef-4319-8063-ca71c03c83a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlways-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD
Version Model NumberINS-5300
Catalog NumberINS-5300
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
GS100815686021207 [Primary]
GS100815686021214 [Package]
Contains: 00815686021207
Package: [5 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-21
Device Publish Date2019-10-11

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