AccessGUDID - DEVICE: FiXcision (EAMIFIX20010)

GUDID

Device Identifier (DI) Information

Brand Name: FiXcision
Version or Model: FIX2001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FIX2001
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIFIX20010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.

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?
63141	Anal fistula circular cutter	A sterile device intended for the circumferential resection of tissue to treat simple anal fistula. It includes a probe for initial exploration of the fistula, a guide with attachable base plate, and cylindrical cutting tool; the cutting tool is intended to be passed down the guide towards the base plate to remove diseased tissue and allow fistula healing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182664	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c09fdfc-9e6d-4255-ab1d-e5072a4d1faa
Public Version Date: April 12, 2019
Public Version Number: 2
DI Record Publish Date: December 14, 2018