Disposable Needle Guide

GUDID 10841912104922

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use
Primary Device ID10841912104922
NIH Device Record Key161ef829-ed44-4605-81ed-2adbe609d6fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Needle Guide
Version Model Number5154
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count250
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
GS100841912104925 [Unit of Use]
GS110841912104922 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2017-04-26

On-Brand Devices [Disposable Needle Guide]

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

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