IU SB Abutment_Non hex Φ4.0

GUDID 08800026104223

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026104223
• NIH Device Record Key: d8da90f6-f731-4881-9078-459a4a6563fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_Non hex Φ4.0
• Version Model Number: IUSB4035NA
• 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	08800026104223 [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

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

Moist Heat or Steam Sterilization

[08800026104223]

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 Φ4.0]

• 08800026109402: IUSB4064NA
• 08800026109396: IUSB4064N
• 08800026109389: IUSB4054NA
• 08800026109372: IUSB4054N
• 08800026109365: IUSB4044NA
• 08800026109358: IUSB4044N
• 08800026109341: IUSB4034NA
• 08800026109334: IUSB4034N
• 08800026109327: IUSB4024NA
• 08800026109310: IUSB4024N
• 08800026109303: IUSB4014NA
• 08800026109297: IUSB4014N
• 08800026104292: IUSB4067NA
• 08800026104285: IUSB4065NA
• 08800026104278: IUSB4057NA
• 08800026104261: IUSB4055NA
• 08800026104254: IUSB4047NA
• 08800026104247: IUSB4045NA
• 08800026104230: IUSB4037NA
• 08800026104223: IUSB4035NA
• 08800026104216: IUSB4027NA
• 08800026104209: IUSB4025NA
• 08800026104193: IUSB4017NA
• 08800026104186: IUSB4015NA
• 08800026103936: IUSB4067N
• 08800026103929: IUSB4065N
• 08800026103912: IUSB4057N
• 08800026103905: IUSB4055N
• 08800026103899: IUSB4047N
• 08800026103882: IUSB4045N
• 08800026103875: IUSB4037N
• 08800026103868: IUSB4035N
• 08800026103851: IUSB4027N
• 08800026103844: IUSB4025N
• 08800026103837: IUSB4017N
• 08800026103820: IUSB4015N