Probe Cover Kits

GUDID 00841912106332

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID00841912106332
NIH Device Record Key96e89b5d-9adf-4737-9805-8be81faad640
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe Cover Kits
Version Model Number2450
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912106332 [Unit of Use]
GS110841912106339 [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 Kits]

108419121007641471
008419121063942270
008419121063322450
008419121063252320
108419121061931930

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