SPiN Access Catheter Adapter, Olympus 190 INS-5902

GUDID 00815686021245

VERAN MEDICAL TECHNOLOGIES INC.

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Primary Device ID00815686021245
NIH Device Record Key3ff425fb-2b0b-4d00-aa1d-09fd6b5d72e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPiN Access Catheter Adapter, Olympus 190
Version Model NumberINS-5902
Catalog NumberINS-5902
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
GS100815686021245 [Primary]

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 Date2020-02-07
Device Publish Date2020-01-30

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