OASIS 8213-2000-33
GUDID 10827002466231
OASIS Wound Matrix
COOK BIOTECH INCORPORATED
Biochemically-interactive dressing| Primary Device ID | 10827002466231 |
| NIH Device Record Key | c343ae02-beba-4f8c-92b3-5417d97ae8fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OASIS |
| Version Model Number | G46623 |
| Catalog Number | 8213-2000-33 |
| 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 |
| 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. |
| 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 | 00827002466234 [Primary] |
| GS1 | 10827002466231 [Package] Contains: 00827002466234 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061711
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 |
On-Brand Devices [OASIS]
| 10827002466279 | OASIS Wound Matrix |
| 10827002466231 | OASIS Wound Matrix |
| 00827002576100 | OASIS Burn Matrix |
| 00827002576094 | OASIS Burn Matrix |
| 00827002576087 | OASIS Burn Matrix |
| 10827002576077 | OASIS Burn Matrix |
| 10827002576060 | OASIS Burn Matrix |
| 10827002576053 | OASIS Burn Matrix |
| 10827002576046 | OASIS Burn Matrix |
| 10827002576039 | OASIS Burn Matrix |
| 10827002576022 | OASIS Burn Matrix |
| 10827002576015 | OASIS Burn Matrix |
| 00827002564664 | OASIS Ultra Tri-Layer Matrix |
| 10827002564654 | OASIS Ultra Tri-Layer Matrix |
| 00827002564640 | OASIS Ultra Tri-Layer Matrix |
| 10827002564630 | OASIS Ultra Tri-Layer Matrix |
| 10827002466262 | OASIS Wound Matrix |
| 10827002466224 | OASIS Wound Matrix |
| 10827002352459 | OASIS Ultra Tri-Layer Matrix |
| 10827002352442 | OASIS Ultra Tri-Layer Matrix |
| 10827002352435 | OASIS Ultra Tri-Layer Matrix |
| 10827002352428 | OASIS Ultra Tri-Layer Matrix |
| 00827002231207 | OASIS Ultra Tri-Layer Matrix |
| 10827002231198 | OASIS Ultra Tri-Layer Matrix |
| 10827002590929 | OASIS XL |
| 10827002466460 | OASIS XL |
| 00827002590922 | OASIS XL |
| 00827002466463 | OASIS XL |
Trademark Results [OASIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OASIS 98865054 not registered Live/Pending |
Oasis Dermatology Group, PLLC 2024-11-21 |
 OASIS 98858621 not registered Live/Pending |
SA Consumer Products, Inc. 2024-11-18 |
 OASIS 98849287 not registered Live/Pending |
Under Her Empire LLC 2024-11-12 |
 OASIS 98830429 not registered Live/Pending |
Thomas Gallaway Corporation 2024-10-31 |
 OASIS 98762169 not registered Live/Pending |
Wind Makers, S.A. de C.V. 2024-09-20 |
 OASIS 98736747 not registered Live/Pending |
Oasis Hill, LLC 2024-09-06 |
 OASIS 98736716 not registered Live/Pending |
Oasis Hill, LLC 2024-09-06 |
 OASIS 98730414 not registered Live/Pending |
Oasis Distillery LLC 2024-09-03 |
 OASIS 98698250 not registered Live/Pending |
Ecolab USA Inc. 2024-08-14 |
 OASIS 98610582 not registered Live/Pending |
AMERICAN HEALTH SERVICE SALES CORPORATION 2024-06-20 |
 OASIS 98608981 not registered Live/Pending |
AEG International, LLC 2024-06-19 |
 OASIS 98605667 not registered Live/Pending |
JASON RIVER 2024-06-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.