PROTEK DILATE

GUDID 08033178019576

SORIN GROUP ITALIA SRL

Vascular dilator, single-use

• Primary Device ID: 08033178019576
• NIH Device Record Key: 49f460c9-7839-4872-a63d-4f3f3e245e34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEK DILATE
• Version Model Number: VAK FEM S STIF
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033178019576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253616

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2026-01-26
• Device Publish Date: 2026-01-16

On-Brand Devices [PROTEK DILATE]

• 08033178019590: VAK FEMORAL PLUS
• 08033178019583: VAK FEMORAL
• 08033178019576: VAK FEM S STIF
• 08033178019552: VAK Dilator Set
• 08033178019545: VAK Jugular