FibermarX Radiopaque Tissue Marker
Viscus Biologics, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013012623 | 3013012623 | Viscus Biologics, LLC. | 1 | N | 2026-01-01 | 26309 Miles Road Suite 1 Cleveland OH US 44128 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850016008008 | FibermarX - FibermarX Radiopaque Tissue Marker | 2167442744 | justin.baker@viscusbiologics.com |
| 00850016008039 | VeraForm - VeraForm Adaptable Tissue Marker | 415-706-5798 | customersupport@viderasurgical.com |
| 00850016008046 | VeraForm - A sterile, single patient use, non-absorbable polymer monofilament that is visible on standard radiographs (e.g., X-ray, mammography, CT). It is passed through soft tissue and tied into place during open, percutaneous, or arthroscopic/laparoscopic/endoscopic procedures and standard surgeon's knots or a continuous running outline are used to quickly mark soft tissue for subsequent imaging or for radiotherapy localization. | 415-706-5798 | customersupport@viderasurgical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 198884 | 1866769854 | K190155 | FibermarX Radiopaque Tissue Marker | IYE | 2019-02-27 |
| 198884 | 1864847956 | K170026 | Radiopaque Tissue Marker | NEU | 2017-06-02 |
| 198884 | 1898606556 | K140820 | XENOMEM WOUND MATRIX | KGN | 2015-06-26 |
| 198884 | 1591248819 | ||||
| 198884 | 1654622281 | ||||
| 198884 | 1937787783 | ||||
| 198884 | 1962306397 |
Viscus Biologics, LLC
Viscus Biologics, LLC
VISCUS BIOLOGICS LLC
2024-01-16
2024-01-16
2021-06-23
2018-01-18
2021-06-23