ProV-Access Sterile Disposable Needle Guide 5402

GUDID 10841912101341

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912101341
NIH Device Record Key0ab5a23d-4afc-4f00-92be-c4e1bf7f595c
Commercial Distribution StatusIn Commercial Distribution
Brand NameProV-Access Sterile Disposable Needle Guide
Version Model Number5402
Catalog Number5402
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
GS100841912101344 [Primary]
GS110841912101341 [Package]
Contains: 00841912101344
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 Number5
Public Version Date2019-10-07
Device Publish Date2016-09-16

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