Director Guideline Verication Kit 4200

GUDID 00841912101092

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID00841912101092
NIH Device Record Key5674ee20-fc96-41b8-9e59-03c48b1f4ffc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirector Guideline Verication Kit
Version Model Number4200
Catalog Number4200
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912101092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-07
Device Publish Date2016-09-16

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