Dental Cartridge Dispenser NA3600

GUDID 00813909010724

Dispenser used with Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental material injection cannula, reusable

• Primary Device ID: 00813909010724
• NIH Device Record Key: 1970e1d0-435b-4168-b58e-09d411904293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Cartridge Dispenser
• Version Model Number: NA3600
• Catalog Number: NA3600
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909010724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100671

FDA Product Code

• EID: Syringe, Restorative And Impression Material
• LYC: Bone Grafting Material, Synthetic

Sterilization

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

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

[00813909010724]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-03-07

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