Flat Plastic cylinder FPC4012T

GUDID 08806388219490

AnyOne Internal Ø4/ L=12

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388219490
NIH Device Record Key525af839-1b74-4d56-aa43-a03324e1f8d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlat Plastic cylinder
Version Model NumberFPC4012
Catalog NumberFPC4012T
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806388219490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388219490]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-06-24

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