RetroFit Sterile Disposable Needle Guide 5319

GUDID 10841912101273

PROTEK MEDICAL PRODUCTS, INC.

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Primary Device ID10841912101273
NIH Device Record Keyed08fb97-be89-438f-856b-15418f346dfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetroFit Sterile Disposable Needle Guide
Version Model Number5319
Catalog Number5319
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
GS100841912101276 [Primary]
GS110841912101273 [Package]
Contains: 00841912101276
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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2016-09-16

On-Brand Devices [RetroFit Sterile Disposable Needle Guide]

008419121033555300
108419121013275325
108419121013105323
108419121013035322
108419121012975321
108419121012805320
108419121012735319
108419121012665318
108419121012595317
108419121012425316
108419121012355315
108419121012285314
108419121012115313
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