APLICOR 3D KIT, Dr. INVIVO Scaffold KIT

GUDID 08809692500124

ROKIT HEALTHCARE Inc.

General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 08809692500124
• NIH Device Record Key: 302dbed6-6e95-4350-ad56-b8bcf02fc6d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APLICOR 3D KIT, Dr. INVIVO Scaffold KIT
• Version Model Number: SK-002
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08809692500124 [Primary]
GS1	18809692500121 [Package]; Package: Carton Box [10 Units]; In Commercial Distribution

FDA Product Code

• KYX: Dispenser, Liquid Medication

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-10-04

On-Brand Devices [APLICOR 3D KIT, Dr. INVIVO Scaffold KIT]

• 08809692500131: SK-003
• 00889692500124: SK-002
• 00889692500117: SK-001
• 08809692500124: SK-002
• 08809692500117: SK-001