Sterile Disposable Needle Guide LNGO2022YX

GUDID 10841912101204

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912101204
NIH Device Record Key0e560fc1-1710-42f8-bf28-37b026f240d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Disposable Needle Guide
Version Model Number5029
Catalog NumberLNGO2022YX
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912101207 [Primary]
GS110841912101204 [Package]
Contains: 00841912101207
Package: [50 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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2016-09-16

On-Brand Devices [Sterile Disposable Needle Guide]

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008419121015285050
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108419121014955045
108419121014885014
008419121014745011
108419121012045029
108419121011985028
108419121011815027
108419121011745026
108419121011675025
108419121000095056
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