Biodesign C-SLH-6H-7X20
GUDID 00827002528666
Biodesign Plastic Surgery Matrix
COOK BIOTECH INCORPORATED
Multi-purpose surgical mesh, collagen, bioabsorbable| Primary Device ID | 00827002528666 |
| NIH Device Record Key | 6c509625-205b-41cd-ac00-3449ee50ef69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biodesign |
| Version Model Number | G52866 |
| Catalog Number | C-SLH-6H-7X20 |
| Company DUNS | 945385862 |
| Company Name | COOK BIOTECH INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002528666 [Primary] |
| GS1 | 10827002528663 [Package] Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K034039
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 | 4 |
| Public Version Date | 2022-03-17 |
| Device Publish Date | 2015-11-03 |
On-Brand Devices [Biodesign]
| 00827002546141 | Biodesign Fistula Plug |
| 00827002546134 | Biodesign Fistula Plug |
| 00827002546127 | Biodesign Fistula Plug |
| 00827002542525 | Biodesign Staple Line Reinforcement |
| 00827002542518 | Biodesign Staple Line Reinforcement |
| 00827002536142 | Biodesign Anal Fistula Plug |
| 00827002525498 | Biodesign Nipple Reconstruction Cylinder |
| 00827002517462 | Biodesign Staple Line Reinforcement |
| 00827002508712 | Biodesign Staple Line Reinforcement |
| 00827002508705 | Biodesign Staple Line Reinforcement |
| 00827002508682 | Biodesign Staple Line Reinforcement |
| 00827002508675 | Biodesign Staple Line Reinforcement |
| 00827002508668 | Biodesign Staple Line Reinforcement |
| 00827002508651 | Biodesign Staple Line Reinforcement |
| 00827002506565 | Biodesign Staple Line Reinforcement |
| 00827002491274 | Biodesign Nipple Reconstruction Cylinder |
| 00827002491267 | Biodesign Nipple Reconstruction Cylinder |
| 00827002347908 | Biodesign Nipple Reconstruction Cylinder |
| 00827002347892 | Biodesign Nipple Reconstruction Cylinder |
| 00827002250079 | Biodesign Staple Line Reinforcement |
| 00827002250062 | Biodesign Staple Line Reinforcement |
| 00827002248274 | Biodesign Staple Line Reinforcement |
| 00827002236622 | Biodesign Staple Line Reinforcement |
| 00827002236547 | Biodesign Enterocutaneous Fistula Plug |
| 00827002236530 | Biodesign Enterocutaneous Fistula Plug |
| 00827002232013 | Biodesign Staple Line Reinforcement |
| 10827002583310 | Tissue Graft |
| 10827002583303 | Tissue Graft |
| 10827002583297 | Tissue Graft |
| 10827002583280 | Tissue Graft |
| 10827002583273 | Tissue Graft |
| 10827002583976 | Biodesign Staple Line Reinforcement |
| 10827002583969 | Biodesign Staple Line Reinforcement |
| 10827002476551 | Biodesign Peyronie's Repair Graft |
| 10827002476544 | Biodesign Peyronie's Repair Graft |
| 10827002138084 | Biodesign 4-Layer Tissue Graft |
| 10827002138077 | Biodesign 4-Layer Tissue Graft |
| 10827002138060 | Biodesign 4-Layer Tissue Graft |
| 10827002131160 | Biodesign 4-Layer Tissue Graft |
| 10827002128481 | Biodesign 4-Layer Tissue Graft |
| 10827002324371 | Biodesign Dural Graft |
| 10827002310923 | Biodesign Dural Graft |
| 10827002310916 | Biodesign Dural Graft |
| 10827002310909 | Biodesign Dural Graft |
| 00827002528666 | Biodesign Plastic Surgery Matrix |
| 00827002528673 | Biodesign Plastic Surgery Matrix |
| 00827002552678 | Biodesign Hernia Graft |
| 00827002552661 | Biodesign Hernia Graft |
| 00827002552654 | Biodesign Hernia Graft |
| 00827002528659 | Biodesign Plastic Surgery Matrix |
Trademark Results [Biodesign]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIODESIGN 98376229 not registered Live/Pending |
Vector Laboratories, Inc. 2024-01-25 |
 BIODESIGN 98375749 not registered Live/Pending |
Vector Laboratories, Inc. 2024-01-25 |
 BIODESIGN 98375633 not registered Live/Pending |
Vector Laboratories, Inc. 2024-01-25 |
 BIODESIGN 78462571 3065214 Dead/Cancelled |
The Queen Family Partnership, LLLP 2004-08-05 |
 BIODESIGN 77679942 3704681 Live/Registered |
Cook Biotech Incorporated 2009-02-27 |
 BIODESIGN 76566578 not registered Dead/Abandoned |
Steven M. Montgomery 2003-12-23 |
 BIODESIGN 76484445 2990023 Dead/Cancelled |
SILIMED - SILICONE E INSTRUMENTAL MÃDICO-CIRÃRGICO E HOSPITALAR LTDA 2003-01-21 |
 BIODESIGN 74397569 1827875 Dead/Cancelled |
Montgomery, Steven M. 1993-06-04 |
 BIODESIGN 74003032 1608949 Dead/Cancelled |
BIODESIGN, INC. 1989-11-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.