ASPIJECT SELF ASPIRATING SYRINGE 01N2020

GUDID 00303620000000

Dental cartridge syringe

SEPTODONT, INC

Syringe-loaded injector, manual, professional

• Primary Device ID: 00303620000000
• NIH Device Record Key: 90619938-0908-4c32-838b-acee17293c7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPIJECT SELF ASPIRATING SYRINGE
• Version Model Number: 01N2020
• Catalog Number: 01N2020
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• 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: 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: true

Customer Support Contacts

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

Device Dimensions

• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter
• Total Volume: 1.8 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002168

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

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

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

[00303620000000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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• 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)