Neurolac NG01-070/03
GUDID 08717703990164
Polyganics Innovations B.V.
Nerve guide, synthetic-polymer, bioabsorbable| Primary Device ID | 08717703990164 |
| NIH Device Record Key | 6793d6f4-6438-434e-b59e-0e58a9153a1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurolac |
| Version Model Number | 7.0 mm |
| Catalog Number | NG01-070/03 |
| 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
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
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 |
| 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 |
| 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 | 08717703990164 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050573
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 | 2024-03-05 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [Neurolac]
| 08717703990188 | 10.0 mm |
| 08717703990171 | 8.0 mm |
| 08717703990164 | 7.0 mm |
| 08717703990157 | 6.0 mm |
| 08717703990140 | 5,0 mm |
| 08717703990133 | 4,0 mm |
Trademark Results [Neurolac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROLAC 76139944 2731116 Live/Registered |
Polyganics B.V. 2000-10-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.