AXA Abutment Screw AXBDAS1604

GUDID 08809931188809

BLUEDIAMOND

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08809931188809
NIH Device Record Key02a3ab86-d0db-462c-8cf2-9b766124d2f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXA Abutment Screw
Version Model NumberAXBDAS1604
Catalog NumberAXBDAS1604
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
GS108809931188809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809931188809]

Moist Heat or Steam Sterilization


[08809931188809]

Moist Heat or Steam Sterilization


[08809931188809]

Moist Heat or Steam Sterilization


[08809931188809]

Moist Heat or Steam Sterilization


[08809931188809]

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

On-Brand Devices [AXA Abutment Screw]

08809985656668BLUEDIAMOND
08809985656651BLUEDIAMOND
08809985656644BLUEDIAMOND
08809931188823BLUEDIAMOND
08809931188816BLUEDIAMOND
08809931188809BLUEDIAMOND

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