IU SB Abutment_Non hex Φ6.0

GUDID 08800026104117

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026104117
• NIH Device Record Key: 148c5d49-209c-42ab-b9a3-05c2a1188ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_Non hex Φ6.0
• Version Model Number: IUSB6037N
• Company DUNS: 688857820
• Company Name: WARANTEC.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	08800026104117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

[08800026104117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-20
• Device Publish Date: 2023-04-12

On-Brand Devices [IU SB Abutment_Non hex Φ6.0]

• 08800026104179: IUSB6067N
• 08800026104162: IUSB6065N
• 08800026104155: IUSB6057N
• 08800026104148: IUSB6055N
• 08800026104131: IUSB6047N
• 08800026104124: IUSB6045N
• 08800026104117: IUSB6037N
• 08800026104100: IUSB6035N
• 08800026104094: IUSB6027N
• 08800026104087: IUSB6025N
• 08800026104070: IUSB6017N
• 08800026104063: IUSB6015N