ProPass

GUDID 00816342025553

ProPass Suture Passer Needle

PARCUS MEDICAL LLC

Suturing unit, single-use

• Primary Device ID: 00816342025553
• NIH Device Record Key: e9dca03b-6c0c-493c-9c78-391c03911f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProPass
• Version Model Number: 11679
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• 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: 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	00816342025553 [Primary]

FDA Product Code

• HWQ: Passer

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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [ProPass]

• 00816342025553: ProPass Suture Passer Needle
• 00816342025546: ProPass Suture Passer without trap door
• 00816342025539: ProPass Suture Passer with trap door