Meg-Ball Package MBOO50P

GUDID 08806388275618

C=5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388275618
• NIH Device Record Key: 5b285e8d-a8e3-4256-9cee-9b894bb27411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meg-Ball Package
• Version Model Number: MBOO50P
• Catalog Number: MBOO50P
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806388275618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192614

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806388275618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-15
• Device Publish Date: 2020-04-07

On-Brand Devices [Meg-Ball Package]

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