Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit 5364

GUDID 10841912106902

Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912106902
NIH Device Record Key85be8e01-bf80-4a76-9530-5e1faef820c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit
Version Model Number5364
Catalog Number5364
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912106905 [Primary]
GS110841912106902 [Package]
Contains: 00841912106905
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

On-Brand Devices [Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit]

10841912106919Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
10841912106902Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
10841912106896Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
10841912106889Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
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