DentaIBT

GUDID 09359215000055

ASIGA PTY LTD

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• Primary Device ID: 09359215000055
• NIH Device Record Key: 6b527ef2-a942-49cf-9c9e-4fa92aa40cca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaIBT
• Version Model Number: 03746
• Company DUNS: 745954045
• Company Name: ASIGA PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	09359215000055 [Primary]

FDA Product Code

• QJJ: Indirect Bonding Tray

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: 2024-02-14
• Device Publish Date: 2024-02-06

Devices Manufactured by ASIGA PTY LTD

• 09359215000031 - DentaGUIDE: 2024-02-14
• 09359215000055 - DentaIBT: 2024-02-14
• 09359215000055 - DentaIBT: 2024-02-14
• 09359215000093 - DentaTRAY: 2024-02-14
• 09359215000161 - DentaTRY A1: 2024-02-14
• 09359215000178 - DentaTRY A2: 2024-02-14
• 09359215000185 - DentaTRY A3: 2024-02-14
• 09359215000192 - DentaTRY B1: 2024-02-14
• 09359215000208 - DentaTRY B2: 2024-02-14