Abutment Screw

GUDID 08800090601611

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

Dental implant system

• Primary Device ID: 08800090601611
• NIH Device Record Key: d5fd1600-ebe7-4b1f-adf8-7b4c586877f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment Screw
• Version Model Number: ATCS
• 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: 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	08800090601611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192197

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800090601611]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [Abutment Screw]

• 08800090601611: ATCS
• 08800177388879: ATCS5
• 08800039368933: MPCSN