COOK C-ECM-PWD-100MG
GUDID 20827002448517
Powder Extracellular Matrix
COOK BIOTECH INCORPORATED
Biochemically-interactive dressing| Primary Device ID | 20827002448517 |
| NIH Device Record Key | 0cbf5d76-0324-4ef8-a431-089f2bfa635b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COOK |
| Version Model Number | G44851 |
| Catalog Number | C-ECM-PWD-100MG |
| 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
| 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 | 20827002448517 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152033
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 | 2019-04-25 |
| Device Publish Date | 2019-04-17 |
Devices Manufactured by COOK BIOTECH INCORPORATED
| 00810179630003 - DURASIS | 2025-02-28 Durasis Dural Graft |
| 00810179630010 - DURASIS | 2025-02-28 Durasis Dural Graft |
| 00810179630027 - DURASIS | 2025-02-28 Durasis Dural Graft |
| 00810179630034 - DURASIS | 2025-02-28 Durasis Dural Graft |
| 10827002349770 - Biodesign | 2024-07-08 Biodesign Duraplasty Graft |
| 10827002349787 - Biodesign | 2024-07-08 Biodesign Duraplasty Graft |
| 10827002349794 - Biodesign | 2024-07-08 Biodesign Duraplasty Graft |
| 10827002349800 - Biodesign | 2024-07-08 Biodesign Duraplasty Graft |
Trademark Results [COOK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOK 98843348 not registered Live/Pending |
Torres, Ian 2024-11-08 |
 COOK 97366039 not registered Live/Pending |
NA Investments LLC 2022-04-15 |
 COOK 90771906 not registered Live/Pending |
NA Investments LLC 2021-06-14 |
 COOK 88106965 5930019 Live/Registered |
Deverell-Balcells, Christopher P 2018-09-06 |
 COOK 86058862 4737428 Live/Registered |
Cook App Pty Ltd 2013-09-09 |
 COOK 86002183 4962226 Live/Registered |
E.Land World Limited 2013-07-03 |
 COOK 77894431 4100586 Dead/Cancelled |
Kaydee Designs Company Inc. 2009-12-16 |
 COOK 77244334 3414311 Live/Registered |
COOK COLLECTION ATTORNEYS, P.L.C. 2007-08-01 |
 COOK 75891199 2412525 Live/Registered |
A. W. Cook Cement Products, Inc. 2000-01-07 |
 COOK 75647246 2635808 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 1999-02-24 |
 COOK 74241990 1755015 Dead/Cancelled |
NILFISK-ADVANCE, INC. 1992-01-31 |
 COOK 73660030 1486038 Dead/Cancelled |
COOK INCORPORATED 1987-05-11 |
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