ULTRA SAFETY PLUS STER SINGLE USE HANDLE 01N3400

GUDID 03760140703168

Single Use white Sterile handle.

SEPTODONT SAS SPECIALITES SEPTODONT

Dental syringe needle, single-use
Primary Device ID03760140703168
NIH Device Record Key50a34461-0168-486a-a03f-f88321b745f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRA SAFETY PLUS STER SINGLE USE HANDLE
Version Model Number01N3400
Catalog Number01N3400
Company DUNS275273795
Company NameSEPTODONT SAS SPECIALITES SEPTODONT
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760140703168 [Primary]

FDA Product Code

EJISyringe, Cartridge

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-15
Device Publish Date2016-09-12

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