AccessGUDID - DEVICE: Suction tube Eicken EM (B057U1030120)

GUDID

Device Identifier (DI) Information

Brand Name: Suction tube Eicken EM
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U1 030 12
Company Name: Scopis GmbH

Primary DI Number: B057U1030120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341702266 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58183	Electromagnetic surgical navigation device tracking system	An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGW	Ear, Nose, And Throat Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37d64da5-0213-48f5-a83f-c372ac1e7975
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: January 04, 2018