STRADIS HEALTHCARE

GUDID M75240473APP0

CUSTOM DENTAL KIT, PERIO, ORAL SURGERY

STRADIS MEDICAL, LLC

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device IDM75240473APP0
NIH Device Record Keyb4287302-b5fb-42a3-8d1e-eddc44aa1518
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRADIS HEALTHCARE
Version Model Number40473APP
Company DUNS174262477
Company NameSTRADIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM
Phone770-962-2425
EmailSERVICE@STRADISHEALTHCARE.COM

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM75240473APP0 [Primary]

FDA Product Code

NYDEndodontic Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-29
Device Publish Date2022-03-21

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