SAFETY PLUS KIT 27G LONG 01N4272

GUDID 03760140703199

100 needles with sterilisable black handle

SEPTODONT SAS SPECIALITES SEPTODONT

Dental syringe needle, single-use

• Primary Device ID: 03760140703199
• NIH Device Record Key: ac24af2d-cc7b-4a77-9195-fc87ace73e2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFETY PLUS KIT 27G LONG
• Version Model Number: 01N4272
• Catalog Number: 01N4272
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760140703199 [Primary]

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[03760140703199]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

• 03760140703335 - BIODENTINE: 2023-06-13 Bioactive dentin substitute
• 03760140703366 - BIODENTINE - 5 PACK: 2023-06-13 Bioactive dentin substitute
• 03701398102709 - Ultra Safety Plus Twist kit 25G Long: 2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized)
• 03701398101986 - Biodentine XP 200: 2022-02-15 Bioactive dentin substitute
• 03701398101993 - Biodentine XP 500: 2022-02-15 Bioactive dentin substitute
• 03701398102556 - BioRoot Flow- 2 g: 2022-02-09 Bioactive mineral Root Canal Sealer
• 03701398102563 - BioRoot Flow-0.5 g: 2022-02-09 Bioactive mineral Root Canal Sealer
• 33760140704371 - Endosolv: 2021-01-14 solvent for endodontic cements