IU SB Abutment_hex Φ4.0

GUDID 08800026103301

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026103301
• NIH Device Record Key: 16f53ebe-7c5c-4393-aef4-e7865d91a5d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_hex Φ4.0
• Version Model Number: IUSB4055HA
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026103301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

Moist Heat or Steam Sterilization

[08800026103301]

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_hex Φ4.0]

• 08800026109228: IUSB4064HA
• 08800026109211: IUSB4064H
• 08800026109204: IUSB4054HA
• 08800026109198: IUSB4054H
• 08800026109181: IUSB4044HA
• 08800026109174: IUSB4044H
• 08800026109167: IUSB4034HA
• 08800026109150: IUSB4034H
• 08800026109143: IUSB4024HA
• 08800026109136: IUSB4024H
• 08800026109129: IUSB4014HA
• 08800026109112: IUSB4014H
• 08800026103332: IUSB4067HA
• 08800026103325: IUSB4065HA
• 08800026103318: IUSB4057HA
• 08800026103301: IUSB4055HA
• 08800026103295: IUSB4047HA
• 08800026103288: IUSB4045HA
• 08800026103271: IUSB4037HA
• 08800026103264: IUSB4035HA
• 08800026103257: IUSB4027HA
• 08800026103240: IUSB4025HA
• 08800026103233: IUSB4017HA
• 08800026103226: IUSB4015HA
• 08800026102977: IUSB4067H
• 08800026102960: IUSB4065H
• 08800026102953: IUSB4057H
• 08800026102946: IUSB4055H
• 08800026102939: IUSB4047H
• 08800026102922: IUSB4045H
• 08800026102915: IUSB4037H
• 08800026102908: IUSB4035H
• 08800026102892: IUSB4027H
• 08800026102885: IUSB4025H
• 08800026102878: IUSB4017H
• 08800026102861: IUSB4015H