Meg-Ball Package MBAROR70P

GUDID 08809708750048

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08809708750048
NIH Device Record Key1fb31b22-3f3b-47ec-bf9b-e18dd532e285
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeg-Ball Package
Version Model NumberMBAROR70P
Catalog NumberMBAROR70P
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
GS108809708750048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

[08809708750048]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-15
Device Publish Date2023-11-07

On-Brand Devices [Meg-Ball Package]

08806388275625C=6
08806388275618C=5
08806388275601C=4
08806388275595C=3
08806388275588C=2
08806388275571C=1
08806388275564C=0
08806388275557C=6
08806388275540C=5
08806388275533C=4
08806388275526C=3
08806388275519C=2
08806388275502C=1
08806388275496C=0
08806388275489C=6/ RC
08806388275472C=5/ RC
08806388275465C=4/ RC
08806388275458C=3/ RC
08806388275441C=2/ RC
08806388275434C=1/ RC
08806388275427C=0/ RC
08806388275410C=6/ NC
08806388275403C=5/ NC
08806388275397C=4/ NC
08806388275380C=3/ NC
08806388275373C=2/ NC
08806388275366C=1/ NC
08806388275359C=0/ NC
08806388275342C=6
08806388275335C=5
08806388275328C=4
08806388275311C=3
08806388275304C=2
08806388275298C=1
08806388275281C=0
08809708750055AnyOne OneStage C=7
08809728994521MBMI20P
08809728994514MBMI10P
08809728994507MBMI00P
08809708750048MBAROR70P
08809708750031MBARON70P
08809708750024MBAR70P
08809708750017MBAO70P
08809728994576MBMI70P
08809728994569MBMI60P
08809728994552MBMI50P
08809728994545MBMI40P
08809728994538MBMI30P
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