AxoGuard Nerve Cap
GUDID 00850828007046
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
AXOGEN CORPORATION
Nerve guide, bioabsorbable, animal-derived| Primary Device ID | 00850828007046 |
| NIH Device Record Key | 3fcedb11-b7d4-410f-93a1-e9d8bb780f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxoGuard Nerve Cap |
| Version Model Number | AGT215 |
| Company DUNS | 113424464 |
| Company Name | AXOGEN CORPORATION |
| 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 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry location at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850828007046 [Primary] |
| GS1 | 10850828007043 [Package] Package: Box [1 Units] In Commercial Distribution |
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 | 3 |
| Public Version Date | 2021-04-19 |
| Device Publish Date | 2017-10-24 |
On-Brand Devices [AxoGuard Nerve Cap]
| 00850828007091 | The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one s |
| 00850828007084 | The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one s |
| 00850828007077 | The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one s |
| 00850828007060 | The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one s |
| 00850828007046 | The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one s |
Trademark Results [AxoGuard Nerve Cap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXOGUARD NERVE CAP 87980544 5771264 Live/Registered |
AxoGen Corporation 2018-02-22 |
 AXOGUARD NERVE CAP 87980543 5801948 Live/Registered |
AxoGen Corporation 2018-02-22 |
 AXOGUARD NERVE CAP 87807482 not registered Live/Pending |
AxoGen Corporation 2018-02-22 |
 AXOGUARD NERVE CAP 87807364 not registered Live/Pending |
AxoGen Corporation 2018-02-22 |
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