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MS-Pen

FDA UDI

Class II (US FDA UDI)

by Söring GmbH

Identity

Trade Name
MS-Pen FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Device Name
Micro instrument, irrigation+aspiration FDA UDI
Model / Reference
92-020 FDA UDI
Description
Micro instrument, irrigation+aspiration FDA UDI

Identifiers

Primary DI / UDI-DI
04250321519194 FDA UDI
510(k) Number
K992026 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.0 Millimeter FDA UDI
Length — 35 Millimeter FDA UDI

Category: Soft-tissue ultrasonic surgical system handpiece, reusable

MS-Pen by Söring GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue ultrasonic surgical system handpiece, reusable.

Cleared under the same submission

K992026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Söring GmbH

Sources (1)

  • FDA UDI 9e2b7880-4b72-4915-a9aa-0a8c1fb473f0 35 fields · synced May 30, 2026