MTA BIOREP MTA-BRP2.2

GUDID 03760260220385

ITENA CLINICAL

Hygroscopic dental cement

• Primary Device ID: 03760260220385
• NIH Device Record Key: c9a8aad6-89b1-4c64-91dc-ae8c9f373429
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTA BIOREP
• Version Model Number: Coffret MTA BIOREP 2 patients
• Catalog Number: MTA-BRP2.2
• Company DUNS: 278261221
• Company Name: ITENA CLINICAL
• Device Count: 2
• 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: false
• 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	03760260220385 [Primary]
GS1	03760260223508 [Unit of Use]

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-01
• Device Publish Date: 2022-11-23

On-Brand Devices [MTA BIOREP ]

• 03760260220392: Coffret MTA BIOREP 5 patients
• 03760260220385: Coffret MTA BIOREP 2 patients