Fortify Flowable FFM-01-KIT
GUDID 00827002590748
Fortify Flowable Extracellular Matrix
COOK BIOTECH INCORPORATED
Collagen wound matrix dressing| Primary Device ID | 00827002590748 |
| NIH Device Record Key | b135c54e-76b0-4c23-8596-d23cca13762f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortify Flowable |
| Version Model Number | G59074 |
| Catalog Number | FFM-01-KIT |
| 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 | true |
| 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 a 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, 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, 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, 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, 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, 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, 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, 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. |
| 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 | 00827002590748 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160136
FDA Product Code
| KGN | Dressing, wound, collagen |
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 | 2021-08-10 |
| Device Publish Date | 2021-08-02 |
On-Brand Devices [Fortify Flowable]
| 00827002590915 | Fortify Flowable Extracellular Matrix |
| 00827002590748 | Fortify Flowable Extracellular Matrix |
Trademark Results [Fortify Flowable]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTIFY FLOWABLE 90298930 not registered Live/Pending |
Sanara MedTech Inc. 2020-11-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.