ProV-Access Vascular Access Needle Guide 5406SNR

GUDID 10841912105561

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use
Primary Device ID10841912105561
NIH Device Record Key702d4702-0d73-4456-9d5e-ef5369b4aa52
Commercial Distribution StatusIn Commercial Distribution
Brand NameProV-Access Vascular Access Needle Guide
Version Model Number5406
Catalog Number5406SNR
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
GS100841912105564 [Primary]
GS110841912105561 [Package]
Contains: 00841912105564
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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