X-SCREEN XSC03

GUDID 18033959221980

Transparent container for transportation of human samples

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959221980
• NIH Device Record Key: 49349dae-53f4-4146-8a24-4849b08b3c3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-SCREEN
• Version Model Number: X-SCREEN
• Catalog Number: XSC03
• Company DUNS: 439659574
• Company Name: STERYLAB SRL
• Device Count: 1
• 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: false
• 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	08033959221983 [Primary]
GS1	18033959221980 [Package]; Contains: 08033959221983; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• FCG: Biopsy Needle

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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [X-SCREEN]

• 18033959221980: Transparent container for transportation of human samples
• 08033959220429: Transparent container for transportation of human samples