PAROJECT 01N2040

GUDID 00303620000024

Dental cartridge syringe

SEPTODONT, INC

Dental anaesthesia syringe, reusable

• Primary Device ID: 00303620000024
• NIH Device Record Key: ad353efc-a3da-42de-a7ec-32c4f9e0dd8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAROJECT
• Version Model Number: 01N2040
• Catalog Number: 01N2040
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Total Volume: 1.8 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904279

FDA Product Code

• EGM: Injector, Jet, Mechanical-Powered

Sterilization

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

[00303620000024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-15

Devices Manufactured by SEPTODONT, INC

• 13760140703608 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (15X20MM) for dental surgery.
• 03760140703618 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (20X30MM) for dental surgery
• 13760140703622 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (30X40MM) for dental surgery.
• 00303620000291 - EARLOOP FACE MASK BLUE 3 PLY (2115): 2020-05-06 FACEMASK BLUE E/L
• 00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116): 2020-05-06 FACEMASK PINK E/L
• 00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130): 2020-05-06 MASK E/L WH L1
• 00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002): 2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
• 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003): 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)