NEUROCAP NC01-020/03
GUDID 08717703990249
Polyganics Innovations B.V.
Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable Nerve guide, synthetic-polymer, bioabsorbable| Primary Device ID | 08717703990249 |
| NIH Device Record Key | 34ff1970-d08b-4549-8539-90e61be0cfc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEUROCAP |
| Version Model Number | 2.0 mm |
| Catalog Number | NC01-020/03 |
| Company DUNS | 489946080 |
| Company Name | Polyganics Innovations B.V. |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, dry place between -18°C and 8°C (0-46°F). |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717703990249 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152684
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 | 2016-02-02 |
On-Brand Devices [NEUROCAP]
| 08717703990317 | 8.0 mm |
| 08717703990300 | 7.0 mm |
| 08717703990294 | 6.0 mm |
| 08717703990287 | 5.0 mm |
| 08717703990270 | 4.0 mm |
| 08717703990263 | 3.0 mm |
| 08717703990256 | 2.5 mm |
| 08717703990249 | 2.0 mm |
| 08717703990232 | 1.5 mm |
Trademark Results [NEUROCAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROCAP 86799355 5152178 Live/Registered |
Polyganics B.V. 2015-10-26 |
 NEUROCAP 86762772 5200773 Live/Registered |
MEMORY MD INC 2015-09-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.