Disposable Needle Guide

GUDID 00841912106455

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID00841912106455
NIH Device Record Key35770371-b759-4f72-a306-1d6a3193f8c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Needle Guide
Version Model Number5445
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count300
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912106455 [Unit of Use]
GS110841912106452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-13

On-Brand Devices [Disposable Needle Guide]

208419121040595055
108419121059435560
108419121058755070
108419121054555285
108419121049395145
108419121049225154
108419121049155250
108419121049085144
108419121048929000
108419121048855531
108419121040525065
008419121064555445
008419121066225480
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