Probe Cover

GUDID 00841912106264

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID00841912106264
NIH Device Record Key5f3e9a7d-efcc-4ebb-89ef-f0911a0768b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe Cover
Version Model Number2217
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, INC.
Device Count250
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
GS100841912106264 [Unit of Use]
GS110841912106261 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-13

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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