INNO Submerged Implant System-Angulated Abutment

GUDID 08809471722518

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw

• Primary Device ID: 08809471722518
• NIH Device Record Key: 55ee2fa0-d752-4f7a-afd6-1ffa6c7d8e40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Submerged Implant System-Angulated Abutment
• Version Model Number: 2SAAR151B
• 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	08809471722518 [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

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

[08809471722518]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-10-28

On-Brand Devices [INNO Submerged Implant System-Angulated Abutment ]

• 08809471722662: 2SANR254
• 08809471722655: 2SANR253
• 08809471722648: 2SANR252
• 08809471722631: 2SANR251
• 08809471722624: 2SANR154
• 08809471722617: 2SANR153
• 08809471722600: 2SANR152
• 08809471722594: 2SANR151
• 08809471722587: 2SAAR254B
• 08809471722570: 2SAAR253B
• 08809471722563: 2SAAR252B
• 08809471722556: 2SAAR251B
• 08809471722549: 2SAAR154B
• 08809471722532: 2SAAR153B
• 08809471722525: 2SAAR152B
• 08809471722518: 2SAAR151B
• 08809471722501: 2SAAR254A
• 08809471722495: 2SAAR253A
• 08809471722488: 2SAAR252A
• 08809471722471: 2SAAR251A
• 08809471722464: 2SAAR154A
• 08809471722457: 2SAAR153A
• 08809471722440: 2SAAR152A
• 08809471722433: 2SAAR151A