Meg-Ball Package MBAROR70P

GUDID 08809708750048

Megagen Implant Co. Ltd

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Primary Device ID	08809708750048
NIH Device Record Key	1fb31b22-3f3b-47ec-bf9b-e18dd532e285
Commercial Distribution Status	In Commercial Distribution
Brand Name	Meg-Ball Package
Version Model Number	MBAROR70P
Catalog Number	MBAROR70P
Company DUNS	687388178
Company Name	Megagen Implant Co. Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	08809708750048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192614

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous