AccessGUDID - DEVICE: Fisturasper (04262358420091)

GUDID

Device Identifier (DI) Information

Brand Name: Fisturasper
Version or Model: M+L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FR003
Company Name: qtec CE-med GmbH

Primary DI Number: 04262358420091
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 344010844 *Terms of Use

Device Description: The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAC	Rasp, Surgical, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry, keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size M+L

Device Record Status

Public Device Record Key: 706dc424-2055-4162-98ff-abe7bbe2194c
Public Version Date: April 04, 2025
Public Version Number: 2
DI Record Publish Date: July 17, 2023