AXA Prosthetic Kit KAXAR3000S

GUDID 08809985669873

XPEED AnyRidge Internal Implant System

Megagen Implant Co. Ltd

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08809985669873
NIH Device Record Key81febff8-3816-4003-9118-34657260f49d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXA Prosthetic Kit
Version Model NumberKAXAR3000S
Catalog NumberKAXAR3000S
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS108809985669873 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


[08809985669873]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-12
Device Publish Date2024-12-04

On-Brand Devices [AXA Prosthetic Kit]

08809985663550Small Kit
08809985663543KAXARI3000S
08809985669873XPEED AnyRidge Internal Implant System

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