INNO Submerged Implant System-Replica

GUDID 08809471724758

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw

• Primary Device ID: 08809471724758
• NIH Device Record Key: 526a8a3c-1434-4707-9d1c-addbf2c3b245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Submerged Implant System-Replica
• Version Model Number: 2SRHR001
• Company DUNS: 688753763
• Company Name: Cowellmedi Co.,Ltd
• Device Count: 1
• DM Exempt: false
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08809471724758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

[08809471724758]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2018-05-24

Devices Manufactured by Cowellmedi Co.,Ltd

• 08800016103281 - Dental Instrument: 2024-08-19
• 08800016103298 - Dental Instrument: 2024-08-19
• 08800016103304 - Dental Instrument: 2024-08-19
• 08800016103984 - Dental Instrument: 2024-08-19
• 08800016103991 - Dental Instrument: 2024-08-19
• 08800016104004 - Dental Instrument: 2024-08-19
• 08800016104042 - Dental Instrument: 2024-08-19
• 08800016104059 - Dental Instrument: 2024-08-19