Retrieval Pouch with Introducer

GUDID 16955797750076

Unimicro Medical Systems (ShenZhen) Co., Ltd.

Tissue extraction bag

• Primary Device ID: 16955797750076
• NIH Device Record Key: 9f8f9f6f-9c6d-47d6-9771-fa6f54b5df12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retrieval Pouch with Introducer
• Version Model Number: MEBS200
• 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	06955797750079 [Primary]
GS1	16955797750076 [Package]; Contains: 06955797750079; Package: [10 Units]; In Commercial Distribution
GS1	36955797750070 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141593

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: 2025-09-04
• Device Publish Date: 2025-08-27

On-Brand Devices [Retrieval Pouch with Introducer]

• 16955797755231: MEBM600
• 16955797755224: MEBM400
• 16955797750083: MEBS400
• 16955797750076: MEBS200