IRRAflow Laser Leveler Package ICLS 010

GUDID 10868643000460

Irras USA, Inc.

Patient monitoring system module, intracranial pressure

• Primary Device ID: 10868643000460
• NIH Device Record Key: f697a000-0952-45d3-8571-ddbee8a99b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRAflow Laser Leveler Package
• Version Model Number: ICLS 010
• Catalog Number: ICLS 010
• Company DUNS: 056999617
• Company Name: Irras USA, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: 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	00868643000463 [Primary]
GS1	10868643000460 [Package]; Contains: 00868643000463; Package: Each [1 Units]; In Commercial Distribution
GS1	20868643000467 [Package]; Contains: 00868643000463; Package: Case [1 Units]; In Commercial Distribution

FDA Product Code

• JXG: Shunt, Central Nervous System And Components

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: 2024-06-18
• Device Publish Date: 2024-06-10