VeraForm 50024
GUDID 00850016008046
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.
VISCUS BIOLOGICS LLC
Imaging lesion localization marker, implantable| Primary Device ID | 00850016008046 |
| NIH Device Record Key | 6d633c86-a3fa-4e2b-9903-c1692c62312d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VeraForm |
| Version Model Number | 01 |
| Catalog Number | 50024 |
| 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 | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
| Length | 72 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016008039 [Primary] |
| GS1 | 00850016008046 [Package] Contains: 00850016008039 Package: carton [5 Units] In Commercial Distribution |
| GS1 | 00850016008053 [Package] Package: case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190155
FDA Product Code
| IYE | Accelerator, Linear, Medical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-01 |
| Device Publish Date | 2021-06-23 |
On-Brand Devices [VeraForm]
| 00850016008046 | A sterile, single patient use, non-absorbable polymer monofilament that is visible on standard |
| 00850016008183 | VeraForm Adaptable Tissue Marker |
Trademark Results [VeraForm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERAFORM 88095352 not registered Live/Pending |
Videra Surgical, Inc. 2018-08-28 |
 VERAFORM 73739134 1524368 Dead/Cancelled |
A. NATTERMANN & CIE. GMBH 1988-07-11 |
 VERAFORM 73228789 1179962 Dead/Cancelled |
A. Nattermann & Cie GmbH 1980-03-03 |
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