Mystic

GUDID 00888937003116

Mystic® II MitySoft® Bell Cup Vacuum-Assist Delivery System

Coopersurgical, Inc.

Foetal vacuum extraction system, manual, single-use

• Primary Device ID: 00888937003116
• NIH Device Record Key: dc0a7b1c-5a90-4317-9f2e-ce6e048dd8e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mystic
• Version Model Number: 10058
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003116 [Primary]
GS1	20888937003110 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	30888937003117 [Package]; Contains: 20888937003110; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011532

FDA Product Code

• HDB: Extractor, Vacuum, Fetal

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: 2016-08-16

On-Brand Devices [Mystic]

• 00888937003116: Mystic® II MitySoft® Bell Cup Vacuum-Assist Delivery System
• 00888937003109: Mystic® M-Style® Mushroom® Cup Vacuum-Assist Delivery System