FibermarX 50008
GUDID 00850016008008
Single use, 36" radiopaque tissue marker in a Tyvek-poly pouch.
VISCUS BIOLOGICS LLC
Imaging lesion localization marker, implantable| Primary Device ID | 00850016008008 |
| NIH Device Record Key | 1e1e5aad-c0b9-4ee8-8401-032ebdab1a23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FibermarX |
| Version Model Number | 01 |
| Catalog Number | 50008 |
| Company DUNS | 031183936 |
| Company Name | VISCUS BIOLOGICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
| Length | 36 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016008008 [Primary] |
| GS1 | 00850016008015 [Package] Package: Carton [5 Units] In Commercial Distribution |
| GS1 | 00850016008022 [Package] Contains: 00850016008015 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170026
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-18 |
Devices Manufactured by VISCUS BIOLOGICS LLC
| 00850016008183 - VeraForm | 2024-01-24 VeraForm Adaptable Tissue Marker |
| 00850016008046 - VeraForm | 2021-07-01 A sterile, single patient use, non-absorbable polymer monofilament that is visible on standard radiographs (e.g., X-ray, mammog |
| 00850016008008 - FibermarX | 2018-07-06Single use, 36" radiopaque tissue marker in a Tyvek-poly pouch. |
| 00850016008008 - FibermarX | 2018-07-06 Single use, 36" radiopaque tissue marker in a Tyvek-poly pouch. |
Trademark Results [FibermarX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBERMARX 87788369 5746804 Live/Registered |
Viscus Biologics LLC 2018-02-07 |
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