Dental Mini Cartridge Dispenser NA4600

GUDID 00813909010762

Dispenser used with Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

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Primary Device ID	00813909010762
NIH Device Record Key	0467f91c-134a-4bcd-bb33-83b2a1c57416
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dental Mini Cartridge Dispenser
Version Model Number	NA4600
Catalog Number	NA4600
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909010762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100671

FDA Product Code

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