Magic Cylinder

GUDID 08800039371834

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

Dental implant system

• Primary Device ID: 08800039371834
• NIH Device Record Key: cf4477d8-8412-4f9c-a8fd-b29b8ef404e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magic Cylinder
• Version Model Number: MTCP45B
• 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: MR Safe
• 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: true
• 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	08800039371834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212517

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800039371834]

Moist Heat or Steam Sterilization

[08800039371834]

Moist Heat or Steam Sterilization

[08800039371834]

Moist Heat or Steam Sterilization

[08800039371834]

Moist Heat or Steam Sterilization

[08800039371834]

Moist Heat or Steam Sterilization

[08800039371834]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [Magic Cylinder]

• 08800039371674: MTCH45
• 08800039371667: MTCH55
• 08800039375948: MTCH45B
• 08800039375931: MTCH55B
• 08800039375924: MTCN45B
• 08800039375917: MTCN55B
• 08800039371834: MTCP45B
• 08800039371827: MTCP55B
• 08800039371636: MTCP45
• 08800039371629: MTCP55