IU SB Abutment_Non hex Φ5.0

GUDID 08800026109440

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026109440
• NIH Device Record Key: 8158e5b1-8064-430e-b7c8-7b16e4e8ebb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_Non hex Φ5.0
• Version Model Number: IUSB5044N
• 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	08800026109440 [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

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

Moist Heat or Steam Sterilization

[08800026109440]

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 Φ5.0]

• 08800026109464: IUSB5064N
• 08800026109457: IUSB5054N
• 08800026109440: IUSB5044N
• 08800026109433: IUSB5034N
• 08800026109426: IUSB5024N
• 08800026109419: IUSB5014N
• 08800026104056: IUSB5067N
• 08800026104049: IUSB5065N
• 08800026104032: IUSB5057N
• 08800026104025: IUSB5055N
• 08800026104018: IUSB5047N
• 08800026104001: IUSB5045N
• 08800026103998: IUSB5037N
• 08800026103981: IUSB5035N
• 08800026103974: IUSB5027N
• 08800026103967: IUSB5025N
• 08800026103950: IUSB5017N
• 08800026103943: IUSB5015N