ALGICELL® Ag DUP88545
GUDID 30381780491679
Calcium Alginate Dressing with Active Antimicrobial Silver
Derma Sciences Canada Inc
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial| Primary Device ID | 30381780491679 |
| NIH Device Record Key | 792a0394-5713-4e3b-a769-ef81383dc5fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALGICELL® Ag |
| Version Model Number | 88545 |
| Catalog Number | DUP88545 |
| Company DUNS | 200564891 |
| Company Name | Derma Sciences Canada Inc |
| 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
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Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do no use if package is opened or damaged |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780491675 [Primary] |
| GS1 | 30381780491679 [Package] Contains: 10381780491675 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080497
FDA Product Code
| FRO | Dressing, wound, drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2018-10-23 |
On-Brand Devices [ALGICELL® Ag]
| 30381780491693 | Calcium Alginate Dressing with Active Antimicrobial Silver |
| 30381780491686 | Calcium Alginate Dressing with Active Antimicrobial Silver |
| 30381780491679 | Calcium Alginate Dressing with Active Antimicrobial Silver |
| 30381780491662 | Calcium Alginate Dressing with Active Antimicrobial Silver |
| 30381780491655 | Calcium Alginate Dressing with Active Antimicrobial Silver |
| 30381780491648 | Calcium Alginate Dressing with Active Antimicrobial Silver |
Trademark Results [ALGICELL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALGICELL 77072072 3375027 Live/Registered |
DERMA SCIENCES, INC. 2006-12-27 |
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