Healing Cap Screw AXHCS16

GUDID 08809977450915

Common

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08809977450915
NIH Device Record Key77730bc7-4e17-46bd-86c2-063671729658
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealing Cap Screw
Version Model NumberAXHCS16
Catalog NumberAXHCS16
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS108809977450915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809977450915]

Moist Heat or Steam Sterilization

[08809977450915]

Moist Heat or Steam Sterilization

[08809977450915]

Moist Heat or Steam Sterilization

[08809977450915]

Moist Heat or Steam Sterilization

[08809977450915]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-18
Device Publish Date2024-07-10

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