Pen

GUDID 04250321519125

Micro instrument, irrigation

Söring GmbH

Soft-tissue ultrasonic surgical system handpiece, reusable
Primary Device ID04250321519125
NIH Device Record Keyae411876-0b6e-4cad-9cf7-bc11b716fef7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePen
Version Model Number91-021
Company DUNS322238346
Company NameSöring GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com
Phone844 476 7464
EmailUDI-inquiry@soering.com

Device Dimensions

Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter
Outer Diameter1.4 Millimeter
Length121 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104250321519125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

[04250321519125]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-17

On-Brand Devices [Pen]

04250321523511Micro instrument, irrigation
04250321519125Micro instrument, irrigation
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.