Visible Balloon Trocar

GUDID 16955797766107

Unimicro Medical Systems (ShenZhen) Co., Ltd.

Laparoscopic access cannula, single-use

• Primary Device ID: 16955797766107
• NIH Device Record Key: ad21fbc8-946c-42e0-8610-f189d9d2bad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visible Balloon Trocar
• Version Model Number: UNTB-RC0510
• Company DUNS: 421327368
• Company Name: Unimicro Medical Systems (ShenZhen) Co., 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06955797766100 [Primary]
GS1	16955797766107 [Package]; Contains: 06955797766100; Package: [5 Units]; In Commercial Distribution
GS1	36955797766101 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141594

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2025-09-11
• Device Publish Date: 2025-09-03

On-Brand Devices [Visible Balloon Trocar]

• 16955797766121: UNTB-RC1210
• 16955797766114: UNTB-RC1110
• 16955797766107: UNTB-RC0510