Closing Screw

GUDID 08800039315364

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

Dental implant system

• Primary Device ID: 08800039315364
• NIH Device Record Key: 9d07ae35-cf8e-4bbd-9072-6fda04ea97a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Closing Screw
• Version Model Number: HISCY
• 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 Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	08800039315364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152520

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-23
• Device Publish Date: 2024-10-15

Devices Manufactured by InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

• 08800177337532 - Magicore S: 2024-12-25
• 08800177337617 - Magicore S: 2024-12-25
• 08800177337624 - Magicore S: 2024-12-25
• 08800177337631 - Magicore S: 2024-12-25
• 08800177337648 - Magicore S: 2024-12-25
• 08800177337723 - Magicore S: 2024-12-25
• 08800177337730 - Magicore S: 2024-12-25
• 08800177337747 - Magicore S: 2024-12-25