Passport SmartTip Trocar 0260-285-100

GUDID 10869257000303

THe Passport SmartTip Trocar is an access device that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations. The Passport SmartTip Trocar is a single use disposable device, not to be resterilized.

BELLUSCURA LTD.

Laparoscopic access cannula, single-use

• Primary Device ID: 10869257000303
• NIH Device Record Key: c3c51d55-683d-41fd-a3f3-65460e94b132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passport SmartTip Trocar
• Version Model Number: 8.5mmx100mm
• Catalog Number: 0260-285-100
• Company DUNS: 221297691
• Company Name: BELLUSCURA LTD.
• 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: true
• 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

Customer Support Contacts

• Phone: 1-844-883-0940
• Email: customerservice@belluscura.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869257000306 [Primary]
GS1	10869257000303 [Package]; Contains: 00869257000306; Package: case [6 Units]; In Commercial Distribution

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-04-25