AccessGUDID - DEVICE: BioHealx Anal Fistula Device (05391546930001)

GUDID

Device Identifier (DI) Information

Brand Name: BioHealx Anal Fistula Device
Version or Model: BH201X1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIGNUM SURGICAL LIMITED

Primary DI Number: 05391546930001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985655045 *Terms of Use

Device Description: The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition. BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use. BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
67592	Anal fistula closure coil	A bioabsorbable implantable device intended to be introduced around an anal fistula tract to repair the fistula by tissue apposition and closure of the internal opening. It is in the form of a synthetic polymer helical coil which, upon insertion via the rectal wall, approximates tissues and closes the fistula channel, thereby promoting natural tissue healing. It is typically available pre-loaded onto a delivery device with a coiled introducer to facilitate implantation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QML	Anal Fistula Closure Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN240007	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: e0748e89-c5be-4f68-8614-ea6f9c7eba46
Public Version Date: September 09, 2025
Public Version Number: 2
DI Record Publish Date: June 25, 2025