SAFETY PLUS KIT 30G X-SHORT 01N4300

GUDID 03760140703205

100 needles with sterilisable black handle

SEPTODONT SAS SPECIALITES SEPTODONT

Dental syringe needle, single-use
Primary Device ID03760140703205
NIH Device Record Key31222732-c485-49fb-86c3-66b63b4beebc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFETY PLUS KIT 30G X-SHORT
Version Model Number01N4300
Catalog Number01N4300
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
GS103760140703205 [Primary]

FDA Product Code

EJISyringe, Cartridge

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[03760140703205]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-15
Device Publish Date2016-09-13

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

03760140703335 - BIODENTINE2023-06-13 Bioactive dentin substitute
03760140703366 - BIODENTINE - 5 PACK2023-06-13 Bioactive dentin substitute
03701398102709 - Ultra Safety Plus Twist kit 25G Long2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized)
03701398101986 - Biodentine XP 2002022-02-15 Bioactive dentin substitute
03701398101993 - Biodentine XP 5002022-02-15 Bioactive dentin substitute
03701398102556 - BioRoot Flow- 2 g2022-02-09 Bioactive mineral Root Canal Sealer
03701398102563 - BioRoot Flow-0.5 g2022-02-09 Bioactive mineral Root Canal Sealer
33760140704371 - Endosolv2021-01-14 solvent for endodontic cements

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.