UCLA abutment

GUDID 08800039379809

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

Dental implant system

• Primary Device ID: 08800039379809
• NIH Device Record Key: 05c9a635-449c-4597-941d-106295f5e1ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCLA abutment
• Version Model Number: FUPN4001
• 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	08800039379809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153350

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

[08800039379809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [UCLA abutment]

• 08800039379847: FUPN4504
• 08800039379830: FUPN4503
• 08800039379823: FUPN4502
• 08800039379816: FUPN4501
• 08800039379809: FUPN4001
• 08800039379793: FUPH4504
• 08800039379786: FUPH4503
• 08800039379779: FUPH4502
• 08800039379762: FUPH4501
• 08800039379755: FUPH4001