Neurotube 531101420011
GUDID 00844735006193
NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Nerve guide, bioabsorbable, synthetic| Primary Device ID | 00844735006193 |
| NIH Device Record Key | 8a77a597-d5e9-4b8b-b3bc-4808de468b54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurotube |
| Version Model Number | GEM0420NT |
| Catalog Number | 531101420011 |
| Company DUNS | 031284586 |
| Company Name | SYNOVIS MICRO COMPANIES ALLIANCE, INC |
| 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 | true |
| 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 | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844735006193 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K983007
FDA Product Code
| JXI | CUFF, NERVE |
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 | 2019-05-01 |
| Device Publish Date | 2019-04-23 |
On-Brand Devices [Neurotube]
| 00844735006193 | NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NE |
| 00844735006186 | The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or sec |
Trademark Results [Neurotube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROTUBE 85010280 4080708 Dead/Cancelled |
Synovis Life Technologies, Inc. 2010-04-09 |
 NEUROTUBE 74529672 1970830 Live/Registered |
SYNOVIS LIFE TECHNOLOGIES, INC. 1994-05-26 |
 NEUROTUBE 73720396 not registered Dead/Abandoned |
MACKINNON, SUSAN E. 1988-04-04 |
NEUROTUBE 73720396 not registered Dead/Abandoned |
DELLON, A. LEE 1988-04-04 |
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