Sterile Disposable Needle Guide LNGC1619FX

GUDID 10841912101174

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use
Primary Device ID10841912101174
NIH Device Record Keyee42938e-56f5-4d1d-8cc7-62590d98d315
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Disposable Needle Guide
Version Model Number5026
Catalog NumberLNGC1619FX
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
GS100841912101177 [Primary]
GS110841912101174 [Package]
Contains: 00841912101177
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]

108419121016865172
108419121016795171
108419121015635058
108419121015325055
008419121015285050
108419121015185049
108419121015015046
108419121014955045
108419121014885014
008419121014745011
108419121012045029
108419121011985028
108419121011815027
108419121011745026
108419121011675025
108419121000095056

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