IH Multi-unit CCM Cylinder AMCC100H

GUDID 08800041355563

SEWON MEDIX IH Multi-unit CCM Cylinder Bridge Set Product, Ø4.8x4.5x12.0x9.65mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041355563
• NIH Device Record Key: 7ce5e8e5-a41a-4e7e-aea9-155d632f7dc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Multi-unit CCM Cylinder
• Version Model Number: AMCC100H
• Catalog Number: AMCC100H
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-770-402-7313
• Email: dukejung@gmail.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041355563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-11-22

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