INNO Submerged Implant System-Milling Abutment

GUDID 08809471722778

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw

• Primary Device ID: 08809471722778
• NIH Device Record Key: a4c0ed41-2cc9-4da7-8055-deafc5210ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO Submerged Implant System-Milling Abutment
• Version Model Number: 2SMNW528
• 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	08809471722778 [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

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

Moist Heat or Steam Sterilization

[08809471722778]

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-Milling Abutment]

• 08809471722785: 2SMNW548
• 08809471722778: 2SMNW528
• 08809471722761: 2SMHW548
• 08809471722754: 2SMHW528
• 08809471722747: 2SMNR448
• 08809471722730: 2SMNR428
• 08809471722723: 2SMHR448
• 08809471722716: 2SMHR428
• 08809471722709: 2SMNM348
• 08809471722693: 2SMNM328
• 08809471722686: 2SMHM348
• 08809471722679: 2SMHM328