Director Sterile Disposable Needle Guide 4013/TL

GUDID 00841912100941

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use
Primary Device ID00841912100941
NIH Device Record Key100e930d-7246-44b2-a991-9cf853c7bd23
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirector Sterile Disposable Needle Guide
Version Model Number4013/TL
Catalog Number4013/TL
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
GS100841912100941 [Primary]

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

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108419121009554014
008419121009414013/TL
108419121009314013

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