AiD Regen

GUDID 08809692507000

ROKIT HEALTHCARE Inc.

CAD/CAM software

• Primary Device ID: 08809692507000
• NIH Device Record Key: a5e0d5e3-00e9-49c8-981a-1bbe51486cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AiD Regen
• Version Model Number: AIDR-001
• Company DUNS: 689004656
• Company Name: ROKIT HEALTHCARE Inc.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809692507000 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2024-11-22
• Device Publish Date: 2024-11-14

Devices Manufactured by ROKIT HEALTHCARE Inc.

• 08809692507000 - AiD Regen: 2024-11-22
• 08809692507000 - AiD Regen: 2024-11-22
• 08809692500117 - APLICOR 3D KIT, Dr. INVIVO Scaffold KIT: 2024-11-15
• 08809692500124 - APLICOR 3D KIT, Dr. INVIVO Scaffold KIT: 2024-11-15
• 08809692501015 - APLICOR 3D, Dr. INVIVO: 2024-11-15
• 00889692500117 - APLICOR 3D KIT, Dr. INVIVO Scaffold KIT: 2024-10-14
• 00889692500124 - APLICOR 3D KIT, Dr. INVIVO Scaffold KIT: 2024-10-14
• 00889692501015 - APLICOR 3D, Dr. INVIVO: 2024-10-14
• 08809692500131 - APLICOR 3D KIT, Dr. INVIVO Scaffold KIT: 2024-10-14