Signum Surgical USA, Inc.
Matched from indexed company URL: Signum Surgical Limited
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3038193698 | 3038193698 | Signum Surgical USA, Inc. | 1 | Y | 2026-01-01 | 175 Strafford Ave Ste One Wayne PA US 19087 |
GUDID Contact Samples
Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.
| Source GUDID | Product | Phone | Email |
|---|
| 05391546930001 | BioHealx Anal Fistula Device - 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. | 6108606577 | carol@signumsurgical.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 339611 | 1478568273 | DEN240007 | BioHealx Anal Fistula Device | QML | 2024-07-01 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|
| QML | 1 | 2024-07-01 |
GUDID
SIGNUM SURGICAL LIMITED
2025-06-25
signumsurgical.com