Magic UCLA Screw Retained Type

GUDID 08800090661493

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system

• Primary Device ID: 08800090661493
• NIH Device Record Key: 0b332fdc-ffa4-4e88-9dd6-e48deb1c0361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magic UCLA Screw Retained Type
• Version Model Number: MPSR45BT
• Company DUNS: 631169224
• Company Name: InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
• Device Count: 1
• DM Exempt: true
• 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	08800090661493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202418

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

[08800090661493]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

On-Brand Devices [Magic UCLA Screw Retained Type ]

• 08800090661509: MPSR55BT
• 08800090661493: MPSR45BT
• 08800090661486: MPSR40BT
• 08800090661479: MPSR55ST
• 08800090661462: MPSR45ST
• 08800090661455: MPSR40ST
• 08800090661448: MPC55BT
• 08800090661431: MPC45BT
• 08800090661424: MPC40BT
• 08800090661417: MPC55ST
• 08800090661400: MPC45ST
• 08800090661394: MPC40ST