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Suction tube Eicken EM

FDA UDI

Class II (US FDA UDI)

by Scopis GmbH

Identity

Trade Name
Suction tube Eicken EM FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables. Suction tubes are provided non-sterile and are intended to be sterilized by the user. Suction tubes are reusable. FDA UDI
Model / Reference
1.0 FDA UDI
Description
The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables. Suction tubes are provided non-sterile and are intended to be sterilized by the user. Suction tubes are reusable. FDA UDI

Identifiers

Catalog Number
U1 030 12 FDA UDI
Primary DI / UDI-DI
B057U1030120 FDA UDI
FDA Product Code
PGW FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

Suction tube Eicken EM by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scopis GmbH

Sources (1)

  • FDA UDI 37d64da5-0213-48f5-a83f-c372ac1e7975 34 fields · synced May 30, 2026