NR Fix

GUDID 08800039315791

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

Dental implant system

• Primary Device ID: 08800039315791
• NIH Device Record Key: 21991b76-e5c5-4138-9f3c-71ace6e3550f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NR Fix
• Version Model Number: FC3009
• 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: true
• 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	08800039315791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202479

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2020-11-03
• Device Publish Date: 2020-10-26

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

• 08800039370370 - Short Abutment: 2025-01-14
• 08800039370387 - Short Abutment: 2025-01-14
• 08800039370394 - Short Abutment: 2025-01-14
• 08800039370400 - Short Abutment: 2025-01-14
• 08800039370417 - Short Abutment: 2025-01-14
• 08800039370424 - Short Abutment: 2025-01-14
• 08800039370431 - Short Abutment: 2025-01-14
• 08800039370448 - Short Abutment: 2025-01-14