VersaCross™ Steerable Access Solution VSTK0103

GUDID 00685447019619

Steerable Access Solution

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447019619
• NIH Device Record Key: 9839b56a-3b14-4a23-936d-f37e38ae65b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaCross™ Steerable Access Solution
• Version Model Number: VSTK0103
• Catalog Number: VSTK0103
• 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	00685447019619 [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™ Steerable Access Solution]

• 00685447019732: Steerable Access Solution
• 00685447019725: Steerable Access Solution
• 00685447019718: Steerable Access Solution
• 00685447019701: Steerable Access Solution
• 00685447019695: Steerable Access Solution
• 00685447019688: Steerable Access Solution
• 00685447019671: Steerable Access Solution
• 00685447019664: Steerable Access Solution
• 00685447019657: Steerable Access Solution
• 00685447019640: Steerable Access Solution
• 00685447019633: Steerable Access Solution
• 00685447019626: Steerable Access Solution
• 00685447019619: Steerable Access Solution
• 00685447019602: Steerable Access Solution