AxoGuard AG0720
GUDID 00827002528031
AxoGuard Nerve Protector
COOK BIOTECH INCORPORATED
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, 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, 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 | 00827002528031 |
| NIH Device Record Key | 6f2ccabc-0692-46a1-b478-7c31e5576ea1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxoGuard |
| Version Model Number | G52803 |
| Catalog Number | AG0720 |
| Company DUNS | 945385862 |
| Company Name | COOK BIOTECH INCORPORATED |
| 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 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002528031 [Primary] |
| GS1 | 10827002528038 [Package] Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132660
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 | 6 |
| Public Version Date | 2022-03-23 |
| Device Publish Date | 2015-11-03 |
On-Brand Devices [AxoGuard]
| 10827002528045 | AxoGuard Nerve Protector |
| 10827002528038 | AxoGuard Nerve Protector |
| 10827002528021 | AxoGuard Nerve Protector |
| 10827002528014 | AxoGuard Nerve Protector |
| 10827002528007 | AxoGuard Nerve Protector |
| 10827002527994 | AxoGuard Nerve Connector |
| 10827002527987 | AxoGuard Nerve Connector |
| 10827002527970 | AxoGuard Nerve Connector |
| 10827002527963 | AxoGuard Nerve Connector |
| 10827002527956 | AxoGuard Nerve Connector |
| 10827002527949 | AxoGuard Nerve Connector |
| 10827002527932 | AxoGuard Nerve Connector |
| 10827002527925 | AxoGuard Nerve Protector |
| 10827002527918 | AxoGuard Nerve Protector |
| 10827002527901 | AxoGuard Nerve Protector |
| 10827002527895 | AxoGuard Nerve Protector |
| 10827002351353 | AxoGuard Nerve Connector |
| 10827002351346 | AxoGuard Nerve Connector |
| 10827002351339 | AxoGuard Nerve Connector |
| 10827002351322 | AxoGuard Nerve Connector |
| 10827002351315 | AxoGuard Nerve Connector |
| 10827002351308 | AxoGuard Nerve Connector |
| 10827002351285 | AxoGuard Nerve Connector |
| 00827002528048 | AxoGuard Nerve Protector |
| 00827002528031 | AxoGuard Nerve Protector |
| 00827002528024 | AxoGuard Nerve Protector |
| 00827002528017 | AxoGuard Nerve Protector |
| 00827002528000 | AxoGuard Nerve Protector |
| 00827002527997 | AxoGuard Nerve Connector |
| 00827002527980 | AxoGuard Nerve Connector |
| 00827002527973 | AxoGuard Nerve Connector |
| 00827002527966 | AxoGuard Nerve Connector |
| 00827002527959 | AxoGuard Nerve Connector |
| 00827002527942 | AxoGuard Nerve Connector |
| 00827002527935 | AxoGuard Nerve Connector |
| 00827002527928 | AxoGuard Nerve Protector |
| 00827002527911 | AxoGuard Nerve Protector |
| 00827002527904 | AxoGuard Nerve Protector |
| 00827002527898 | AxoGuard Nerve Protector |
| 00827002351356 | AxoGuard Nerve Connector |
| 00827002351349 | AxoGuard Nerve Connector |
| 00827002351332 | AxoGuard Nerve Connector |
| 00827002351325 | AxoGuard Nerve Connector |
| 00827002351318 | AxoGuard Nerve Connector |
| 00827002351301 | AxoGuard Nerve Connector |
| 00827002351288 | AxoGuard Nerve Connector |
Trademark Results [AxoGuard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXOGUARD 77604199 3703251 Live/Registered |
AXOGEN CORPORATION 2008-10-30 |
 AXOGUARD 77604196 3703250 Live/Registered |
AXOGEN CORPORATION 2008-10-30 |
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