SAFETY PLUS KIT 27G SHORT 01N4271

GUDID 03760140703182

100 needles with sterilisable black handle

SEPTODONT SAS SPECIALITES SEPTODONT

Dental syringe needle, single-use
Primary Device ID03760140703182
NIH Device Record Key55281e28-a451-4294-8052-2970a91b7cde
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFETY PLUS KIT 27G SHORT
Version Model Number01N4271
Catalog Number01N4271
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
GS103760140703182 [Primary]

FDA Product Code

EJISyringe, Cartridge

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[03760140703182]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-15
Device Publish Date2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

03701398108510 - Biodentine Applicator (Gun) 2024-12-09 Device for extrusion of dentine substitute.
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

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