Meg-Rhein DR55

GUDID 08806388212088

AnyOne Internal C=5.5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388212088
• NIH Device Record Key: a8758f56-6ad2-4130-a3b9-df4241ba2ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meg-Rhein
• Version Model Number: DR55
• Catalog Number: DR55
• 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	08806388212088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388212088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-24

On-Brand Devices [Meg-Rhein]

• 08806388212088: AnyOne Internal C=5.5
• 08806388212064: AnyOne Internal C=3.5
• 08806388212040: AnyOne Internal C=1.5
• 08806388211906: AnyOne Internal C=0