Vivosorb FS01-130/20
GUDID 08717703990218
Polyganics Innovations B.V.
Multi-purpose surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 08717703990218 |
| NIH Device Record Key | 12b0e48d-89ef-4b1b-b719-28a202619e0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivosorb |
| Version Model Number | 10x13 cm |
| Catalog Number | FS01-130/20 |
| Company DUNS | 489946080 |
| Company Name | Polyganics Innovations B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
| Width | 10 Centimeter |
| Length | 13 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717703990218 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042811
FDA Product Code
| JXI | Cuff, Nerve |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [Vivosorb]
| 08717703990324 | 12x17 cm |
| 08717703990218 | 10x13 cm |
| 08717703990201 | 5x7 cm |
| 08717703990195 | 2x3cm |
Trademark Results [Vivosorb]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVOSORB 76299379 2749386 Dead/Cancelled |
Polyganics B.V. 2001-08-15 |
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