Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z3)

GUDID 00810118104237

Rotary/reciprocating endodontic file/rasp, single-use

Primary Device ID	00810118104237
NIH Device Record Key	6a20ebff-eb27-48bd-9d2b-33ea88a89107
Commercial Distribution Status	In Commercial Distribution
Brand Name	Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z3)
Version Model Number	ZBS31ZPRO3
Company DUNS	185497372
Company Name	NUSMILE, LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00810118104237 [Primary]

EKS	File, Pulp Canal, Endodontic

Steralize Prior To Use	false
Device Is Sterile	false

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