ProV-Access Vascular Access Needle Guide Kit 5431

GUDID 10841912101440

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use
Primary Device ID10841912101440
NIH Device Record Key007a6c24-8f63-4d61-a775-34ff8061b953
Commercial Distribution StatusIn Commercial Distribution
Brand NameProV-Access Vascular Access Needle Guide Kit
Version Model Number5431
Catalog Number5431
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
GS100841912101443 [Primary]
GS110841912101440 [Package]
Contains: 00841912101443
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

On-Brand Devices [ProV-Access Vascular Access Needle Guide Kit]

108419121057145415
108419121046945432
108419121014405431
108419121014335430

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