AccessGUDID - DEVICE: FlexPointer 1.5 (EFIAE0120041)

GUDID

Device Identifier (DI) Information

Brand Name: FlexPointer 1.5
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fiagon GmbH

Primary DI Number: EFIAE0120041
Issuing Agency: HIBCC
Commercial Distribution End Date: January 23, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 312623008 *Terms of Use

Device Description: The product FlexPointer 1.5 are product variants of a navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

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?
45199	Multi-purpose stereotactic surgery system	An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided 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 [?]
K150473	000

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
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e691c1fa-c25c-4dc2-af4f-cba4202bd19f
Public Version Date: January 23, 2025
Public Version Number: 9
DI Record Publish Date: August 09, 2016