Director Sterile Disposable Needle Guide 4015

GUDID 10841912100962

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912100962
NIH Device Record Key34ff85f2-256a-45ef-af96-c48b04c4b586
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirector Sterile Disposable Needle Guide
Version Model Number4015
Catalog Number4015
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912100965 [Primary]
GS110841912100962 [Package]
Contains: 00841912100965
Package: [24 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 Number5
Public Version Date2019-10-07
Device Publish Date2016-09-16

On-Brand Devices [Director Sterile Disposable Needle Guide]

108419121045024016/TL
108419121010824025
108419121010754023
008419121010614022/TL
108419121010514022
108419121010444021
108419121010204019
008419121010164018/TL
108419121010064018
108419121009864016
008419121009724015/TL
108419121009624015
108419121009554014
008419121009414013/TL
108419121009314013
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