Fortify FTRG-1X10
GUDID 00827002590595
Fortify TRG Tissue Repair Graft
COOK BIOTECH INCORPORATED
Multi-purpose surgical mesh, collagen, bioabsorbable| Primary Device ID | 00827002590595 |
| NIH Device Record Key | 4249e5e7-7e3f-4fb4-aa78-2d4a5532e8ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortify |
| Version Model Number | G59059 |
| Catalog Number | FTRG-1X10 |
| 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 | 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
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 a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002590595 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191696
FDA Product Code
| FTM | Mesh, surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-03-31 |
| Device Publish Date | 2021-05-07 |
On-Brand Devices [Fortify]
| 10827002590660 | Fortify TRG Tissue Repair Graft |
| 10827002590653 | Fortify TRG Tissue Repair Graft |
| 10827002590646 | Fortify TRG Tissue Repair Graft |
| 10827002590639 | Fortify TRG Tissue Repair Graft |
| 10827002590622 | Fortify TRG Tissue Repair Graft |
| 10827002590615 | Fortify TRG Tissue Repair Graft |
| 10827002590608 | Fortify TRG Tissue Repair Graft |
| 10827002590592 | Fortify TRG Tissue Repair Graft |
| 00827002590663 | Fortify TRG Tissue Repair Graft |
| 00827002590656 | Fortify TRG Tissue Repair Graft |
| 00827002590649 | Fortify TRG Tissue Repair Graft |
| 00827002590632 | Fortify TRG Tissue Repair Graft |
| 00827002590625 | Fortify TRG Tissue Repair Graft |
| 00827002590618 | Fortify TRG Tissue Repair Graft |
| 00827002590601 | Fortify TRG Tissue Repair Graft |
| 00827002590595 | Fortify TRG Tissue Repair Graft |
Trademark Results [Fortify]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTIFY 98838426 not registered Live/Pending |
Red Diamond, Inc. 2024-11-05 |
 FORTIFY 98692511 not registered Live/Pending |
Filters Delivered L.L.C. 2024-08-10 |
 FORTIFY 98530703 not registered Live/Pending |
FORTIFY EDUCATION INC. 2024-05-02 |
 FORTIFY 97844389 not registered Live/Pending |
Nouri Life, LLC 2023-03-17 |
 FORTIFY 97796648 not registered Live/Pending |
Soma Products LLC 2023-02-15 |
 FORTIFY 97607648 not registered Live/Pending |
Orchid Orthopedic Solutions, LLC 2022-09-26 |
 FORTIFY 97590501 not registered Live/Pending |
Ark Naturals Company 2022-09-14 |
 FORTIFY 97480131 not registered Live/Pending |
NewEraSOS, Inc. 2022-06-28 |
 FORTIFY 90836515 not registered Live/Pending |
ROB-SEE-CO, LLC 2021-07-19 |
 FORTIFY 90640252 not registered Live/Pending |
Colgate-Palmolive Company 2021-04-12 |
 FORTIFY 90489380 not registered Live/Pending |
Sanara MedTech Inc. 2021-01-26 |
 FORTIFY 90480060 not registered Live/Pending |
Aloha Exports LLC 2021-01-21 |
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