ProV-Access Vascular Access Needle Guide 5404SNR

GUDID 10841912105547

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912105547
NIH Device Record Key88bd899e-f807-4f96-89d1-6c7bfbc65744
Commercial Distribution StatusIn Commercial Distribution
Brand NameProV-Access Vascular Access Needle Guide
Version Model Number5404
Catalog Number5404SNR
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, 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
GS100841912105540 [Primary]
GS110841912105547 [Package]
Contains: 00841912105540
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-04-27

On-Brand Devices [ProV-Access Vascular Access Needle Guide]

108419121055615406
108419121055545405
108419121055475404
108419121055305403
108419121055235402
108419121055165401

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