PLEATMAN SAC, Disposable Tissue Removal System

GUDID 00821925009936

Gyrus Acmi, Inc.

Tissue extraction bag

• Primary Device ID: 00821925009936
• NIH Device Record Key: e895ce0e-ad8c-4f04-8330-e14aa549f877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLEATMAN SAC, Disposable Tissue Removal System
• Version Model Number: 004942-901
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: false
• 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	00821925009936 [Package]; Contains: 00821925037915; Package: [20 Units]; In Commercial Distribution
GS1	00821925037915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923945

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: 2018-07-06
• Device Publish Date: 2016-10-07

On-Brand Devices [PLEATMAN SAC, Disposable Tissue Removal System]

• 00821925009431: 004942-903
• 00821925009936: 004942-901