NeuroShield
GUDID 07640181710201
NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.
Monarch Bioimplants GmbH
Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, bioabsorbable, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived Nerve guide, animal-derived| Primary Device ID | 07640181710201 |
| NIH Device Record Key | 115afdb5-d519-4b54-a3be-d83b2e907c54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroShield |
| Version Model Number | NS4030 |
| Company DUNS | 480144102 |
| Company Name | Monarch Bioimplants GmbH |
| 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
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640181710010 [Primary] |
| GS1 | 07640181710201 [Package] Contains: 07640181710010 Package: Shipping carton [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190246
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 | 2022-04-28 |
| Device Publish Date | 2022-04-20 |
On-Brand Devices [NeuroShield]
| 07640181710201 | NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve inj |
| 07640181711208 | NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve inj |
Trademark Results [NeuroShield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROSHIELD 97257392 not registered Live/Pending |
Midlink LLC 2022-02-08 |
 NEUROSHIELD 87602401 not registered Dead/Abandoned |
In-Med Prognostics L3C 2017-09-10 |
 NEUROSHIELD 87117681 not registered Dead/Abandoned |
BAUER INNOVATIONS US, LLC 2016-07-27 |
 NEUROSHIELD 85324932 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2011-05-19 |
 NEUROSHIELD 79259021 not registered Dead/Abandoned |
SENESCENCE LIFE SCIENCES PTE. LTD. 2019-01-15 |
 NEUROSHIELD 79241162 5917168 Live/Registered |
Monarch Bioimplants GmbH 2018-06-18 |
 NEUROSHIELD 79222791 5582909 Live/Registered |
Monarch Bioimplants GmbH 2017-09-19 |
 NEUROSHIELD 77344742 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2007-12-05 |
 NEUROSHIELD 75389682 2803862 Dead/Cancelled |
Mednova Limited 1997-11-13 |
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