General Purpose Probe Cover VPC0648

GUDID 00841912100125

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile
Primary Device ID00841912100125
NIH Device Record Key1f2c26b4-7f4e-422d-aa02-da322e9fd507
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeneral Purpose Probe Cover
Version Model Number2008
Catalog NumberVPC0648
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912100125 [Primary]
GS110841912100122 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [General Purpose Probe Cover]

008419121001252008
008419121001182007
108419121070532323

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