VersaCross™ Large Access Solution VLAK0109

GUDID 00685447019565

Large Access Solution

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447019565
• NIH Device Record Key: e081e4f7-dc53-4665-8d63-63a00f32288d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross™ Large Access Solution
• Version Model Number: VLAK0109
• Catalog Number: VLAK0109
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447019565 [Primary]

FDA Product Code

• OFK: Percutaneous atrial catheter kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-05
• Device Publish Date: 2025-02-25

On-Brand Devices [VersaCross™ Large Access Solution]

• 00685447019596: Large Access Solution
• 00685447019589: Large Access Solution
• 00685447019572: Large Access Solution
• 00685447019565: Large Access Solution
• 00685447019558: Large Access Solution