Ultra Safety Plus Twist kit 25G Long

GUDID 03701398102709

100 needles 25G long (Red) and 1 handle (to be sterilized)

SEPTODONT SAS SPECIALITES SEPTODONT

Dental anaesthesia syringe, reusable
Primary Device ID03701398102709
NIH Device Record Keyc834ad51-1ee7-464b-b10f-a41321c010be
Commercial Distribution Discontinuation2022-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameUltra Safety Plus Twist kit 25G Long
Version Model Number01N4552
Company DUNS275273795
Company NameSEPTODONT SAS SPECIALITES SEPTODONT
Device Count101
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103701398102709 [Direct Marking]
GS103701398103232 [Primary]
GS103701398105281 [Primary]
GS103701398105298 [Primary]
GS103701398105304 [Primary]
GS103701398105311 [Primary]
GS103701398105328 [Primary]

FDA Product Code

EJISyringe, Cartridge

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[03701398102709]

Moist Heat or Steam Sterilization


[03701398102709]

Moist Heat or Steam Sterilization


[03701398102709]

Moist Heat or Steam Sterilization


[03701398102709]

Moist Heat or Steam Sterilization


[03701398102709]

Moist Heat or Steam Sterilization


[03701398102709]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-09-30

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 Long2022-10-10100 needles 25G long (Red) and 1 handle (to be sterilized)
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.