MS-Pen

GUDID 04250321519194

Micro instrument, irrigation+aspiration

Söring GmbH

Soft-tissue ultrasonic surgical system handpiece, reusable

• Primary Device ID: 04250321519194
• NIH Device Record Key: 9e2b7880-4b72-4915-a9aa-0a8c1fb473f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MS-Pen
• Version Model Number: 92-020
• Company DUNS: 322238346
• Company Name: Söring GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 2 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250321519194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992026

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

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

[04250321519194]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [MS-Pen]

• 04250321519224: Micro instrument, irrigation+aspiration
• 04250321519200: Micro instrument, irrigation+aspiration
• 04250321519194: Micro instrument, irrigation+aspiration