FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHealx Anal Fistula Device
DI: 05391546930001
·
Model: BH201X1
·
SIGNUM SURGICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioHealx Anal Fistula Device
- Primary DI
- 05391546930001
- Version / Model
- BH201X1
- Company Name
- SIGNUM SURGICAL LIMITED
- Labeler DUNS
- 985655045
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-25
- Public Version
- 2
- Public Version Date
- 2025-09-09
- Public Version Status
- Update
- Public Device Record Key
- e0748e89-c5be-4f68-8614-ea6f9c7eba46
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QML | Anal Fistula Closure Device | General, Plastic Surgery | 878.4835 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391546930001 | GS1 | ||||
| Package | 05391546930018 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 6108606577
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240007 | 000 |