ANCHOR PLUS/NEO ANCHOR PLUS

GUDID 08809488210091

KJMEDITECH.CO.,LTD

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• Primary Device ID: 08809488210091
• NIH Device Record Key: cfecc811-5d59-4ef5-b65e-0d068ea3a721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCHOR PLUS/NEO ANCHOR PLUS
• Version Model Number: MS-1410
• Company DUNS: 688476027
• Company Name: KJMEDITECH.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: true
• 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	08809488210091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053629

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-03
• Device Publish Date: 2019-08-26

On-Brand Devices [ANCHOR PLUS/NEO ANCHOR PLUS]

• 08809488210251: MSS-1612
• 08809488210244: MSS-1610
• 08809488210237: MSS-1608
• 08809488210220: MSS-1607
• 08809488210213: MSS-1606
• 08809488210206: MSS-1412
• 08809488210190: MSS-1410
• 08809488210183: MSS-1408
• 08809488210176: MSS-1407
• 08809488210169: MSS-1406
• 08809488210152: MS-1612
• 08809488210145: MS-1610
• 08809488210138: MS-1608
• 08809488210121: MS-1607
• 08809488210114: MS-1606
• 08809488210107: MS-1412
• 08809488210091: MS-1410
• 08809488210084: MS-1408
• 08809488210077: MS-1407
• 08809488210060: MS-1406