Probe Cover

GUDID 20841912102888

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile
Primary Device ID20841912102888
NIH Device Record Key3eca28bf-2ef2-4191-84d6-1f07567fa46f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe Cover
Version Model Number0007
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count500
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912102884 [Unit of Use]
GS120841912102888 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

On-Brand Devices [Probe Cover]

208419121028880007
008419121063562257
008419121062642217

Trademark Results [Probe Cover]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROBE COVER
PROBE COVER
97750202 not registered Live/Pending
Zhou, Haiting
2023-01-11

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